Trial Outcomes & Findings for Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (NCT NCT04470050)
NCT ID: NCT04470050
Last Updated: 2023-10-26
Results Overview
Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
225 participants
Primary outcome timeframe
Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose
Results posted on
2023-10-26
Participant Flow
Participant milestones
| Measure |
Morphine Maintenance, Then Cohort 1- 30 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 30 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 2- 60 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 60 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 3- 90 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 90 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 4- 120 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 120 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 5- 180 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 180 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 6- 240 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 240 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 7- Placebo
Oral morphine 30 mg immediate tablets, then sublingual film containing placebo
|
|---|---|---|---|---|---|---|---|
|
Opioid Maintenance Phase
STARTED
|
29
|
35
|
31
|
32
|
40
|
33
|
25
|
|
Opioid Maintenance Phase
COMPLETED
|
17
|
17
|
21
|
19
|
21
|
15
|
25
|
|
Opioid Maintenance Phase
NOT COMPLETED
|
12
|
18
|
10
|
13
|
19
|
18
|
0
|
|
Double-blind Treatment Phase
STARTED
|
17
|
17
|
21
|
19
|
21
|
15
|
25
|
|
Double-blind Treatment Phase
COMPLETED
|
7
|
5
|
6
|
7
|
5
|
6
|
6
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
10
|
12
|
15
|
12
|
16
|
9
|
19
|
Reasons for withdrawal
| Measure |
Morphine Maintenance, Then Cohort 1- 30 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 30 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 2- 60 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 60 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 3- 90 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 90 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 4- 120 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 120 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 5- 180 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 180 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 6- 240 Micrograms
Oral morphine 30 mg immediate tablets, then sublingual film containing 240 micrograms BXCL501 (Dexmedetomidine)
|
Morphine Maintenance, Then Cohort 7- Placebo
Oral morphine 30 mg immediate tablets, then sublingual film containing placebo
|
|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Phase
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
10
|
12
|
15
|
11
|
15
|
9
|
19
|
Baseline Characteristics
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
Cohort 1- 30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Cohort 2- 60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Cohort 3- 90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Cohort 4- 120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Cohort 5- 180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Cohort 6- 240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine or Placebo
Dexmedetomidine (BXCL501): Sublingual Film
Placebo: Sublingual Placebo film
|
Pooled Placebo
n=25 Participants
Placebo: Sublingual Placebo film
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
117 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 13.88 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 12.56 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 9.55 • n=4 Participants
|
42.9 years
STANDARD_DEVIATION 9.57 • n=21 Participants
|
42.0 years
STANDARD_DEVIATION 11.86 • n=8 Participants
|
42.1 years
STANDARD_DEVIATION 10.97 • n=8 Participants
|
42.0 years
STANDARD_DEVIATION 10.99 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
99 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
84 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Height
|
170.32 cm
STANDARD_DEVIATION 6.933 • n=5 Participants
|
170.14 cm
STANDARD_DEVIATION 7.255 • n=7 Participants
|
176.46 cm
STANDARD_DEVIATION 10.176 • n=5 Participants
|
171.57 cm
STANDARD_DEVIATION 10.942 • n=4 Participants
|
172.25 cm
STANDARD_DEVIATION 10.349 • n=21 Participants
|
174.17 cm
STANDARD_DEVIATION 7.998 • n=8 Participants
|
174.42 cm
STANDARD_DEVIATION 9.220 • n=8 Participants
|
172.92 cm
STANDARD_DEVIATION 9.283 • n=24 Participants
|
|
Weight
|
71.22 kg
STANDARD_DEVIATION 10.604 • n=5 Participants
|
66.38 kg
STANDARD_DEVIATION 10.159 • n=7 Participants
|
78.05 kg
STANDARD_DEVIATION 13.827 • n=5 Participants
|
82.04 kg
STANDARD_DEVIATION 17.999 • n=4 Participants
|
83.65 kg
STANDARD_DEVIATION 26.189 • n=21 Participants
|
83.51 kg
STANDARD_DEVIATION 21.313 • n=8 Participants
|
79.23 kg
STANDARD_DEVIATION 21.480 • n=8 Participants
|
77.98 kg
STANDARD_DEVIATION 19.085 • n=24 Participants
|
|
Body Mass Index
|
24.65 kg/m^2
STANDARD_DEVIATION 4.135 • n=5 Participants
|
22.95 kg/m^2
STANDARD_DEVIATION 3.217 • n=7 Participants
|
25.05 kg/m^2
STANDARD_DEVIATION 3.824 • n=5 Participants
|
28.16 kg/m^2
STANDARD_DEVIATION 7.856 • n=4 Participants
|
28.05 kg/m^2
STANDARD_DEVIATION 8.248 • n=21 Participants
|
27.47 kg/m^2
STANDARD_DEVIATION 6.589 • n=8 Participants
|
26.21 kg/m^2
STANDARD_DEVIATION 7.721 • n=8 Participants
|
26.12 kg/m^2
STANDARD_DEVIATION 6.498 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dosePopulation: Full Analysis Set (FAS)
Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=24 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Peak SOWS Scores at Baseline and Over Time
Day 14 Post-dose
|
2.4 score on a scale
Standard Deviation 2.64
|
2.8 score on a scale
Standard Deviation 3.83
|
2.7 score on a scale
Standard Deviation 3.88
|
2.1 score on a scale
Standard Deviation 2.54
|
1.7 score on a scale
Standard Deviation 2.34
|
1.2 score on a scale
Standard Deviation 1.83
|
4.3 score on a scale
Standard Deviation 9.67
|
|
Peak SOWS Scores at Baseline and Over Time
Day 12 Post-dose
|
5.4 score on a scale
Standard Deviation 5.65
|
3.2 score on a scale
Standard Deviation 3.03
|
2.8 score on a scale
Standard Deviation 3.54
|
2.9 score on a scale
Standard Deviation 3.83
|
5.7 score on a scale
Standard Deviation 5.10
|
5.2 score on a scale
Standard Deviation 3.76
|
7.0 score on a scale
Standard Deviation 11.38
|
|
Peak SOWS Scores at Baseline and Over Time
Day 13 Post-dose
|
5.0 score on a scale
Standard Deviation 4.12
|
5.4 score on a scale
Standard Deviation 6.99
|
4.0 score on a scale
Standard Deviation 3.90
|
4.0 score on a scale
Standard Deviation 4.57
|
3.3 score on a scale
Standard Deviation 2.29
|
3.5 score on a scale
Standard Deviation 1.38
|
4.3 score on a scale
Standard Deviation 6.22
|
|
Peak SOWS Scores at Baseline and Over Time
Baseline, Pre-Dose, Day 6
|
3.6 score on a scale
Standard Deviation 3.24
|
5.2 score on a scale
Standard Deviation 3.86
|
6.0 score on a scale
Standard Deviation 5.45
|
4.7 score on a scale
Standard Deviation 4.64
|
5.0 score on a scale
Standard Deviation 4.43
|
6.5 score on a scale
Standard Deviation 7.38
|
6.2 score on a scale
Standard Deviation 6.93
|
|
Peak SOWS Scores at Baseline and Over Time
Day 6 Post-dose
|
4.0 score on a scale
Standard Deviation 3.30
|
9.1 score on a scale
Standard Deviation 7.49
|
7.7 score on a scale
Standard Deviation 5.01
|
8.6 score on a scale
Standard Deviation 7.05
|
9.0 score on a scale
Standard Deviation 7.20
|
11.2 score on a scale
Standard Deviation 6.27
|
7.5 score on a scale
Standard Deviation 7.08
|
|
Peak SOWS Scores at Baseline and Over Time
Day 7 Post-dose
|
8.8 score on a scale
Standard Deviation 8.19
|
9.6 score on a scale
Standard Deviation 7.09
|
9.3 score on a scale
Standard Deviation 6.10
|
10.7 score on a scale
Standard Deviation 7.20
|
14.9 score on a scale
Standard Deviation 9.42
|
14.2 score on a scale
Standard Deviation 11.17
|
10.2 score on a scale
Standard Deviation 8.10
|
|
Peak SOWS Scores at Baseline and Over Time
Day 8 Post-dose
|
9.8 score on a scale
Standard Deviation 7.86
|
7.4 score on a scale
Standard Deviation 7.23
|
8.6 score on a scale
Standard Deviation 5.86
|
8.0 score on a scale
Standard Deviation 6.46
|
10.8 score on a scale
Standard Deviation 7.63
|
12.0 score on a scale
Standard Deviation 7.59
|
9.1 score on a scale
Standard Deviation 7.50
|
|
Peak SOWS Scores at Baseline and Over Time
Day 9 Post-dose
|
6.8 score on a scale
Standard Deviation 3.35
|
6.0 score on a scale
Standard Deviation 3.27
|
6.5 score on a scale
Standard Deviation 4.72
|
6.9 score on a scale
Standard Deviation 6.44
|
10.2 score on a scale
Standard Deviation 6.44
|
11.5 score on a scale
Standard Deviation 9.27
|
8.0 score on a scale
Standard Deviation 9.74
|
|
Peak SOWS Scores at Baseline and Over Time
Day 10 Post-dose
|
6.7 score on a scale
Standard Deviation 6.02
|
4.3 score on a scale
Standard Deviation 2.66
|
5.3 score on a scale
Standard Deviation 5.28
|
4.6 score on a scale
Standard Deviation 5.87
|
8.5 score on a scale
Standard Deviation 5.22
|
8.5 score on a scale
Standard Deviation 5.32
|
4.1 score on a scale
Standard Deviation 3.80
|
|
Peak SOWS Scores at Baseline and Over Time
Day 11 Post-dose
|
4.0 score on a scale
Standard Deviation 3.96
|
3.8 score on a scale
Standard Deviation 4.38
|
3.4 score on a scale
Standard Deviation 3.64
|
2.5 score on a scale
Standard Deviation 2.56
|
7.2 score on a scale
Standard Deviation 6.34
|
4.8 score on a scale
Standard Deviation 3.25
|
5.1 score on a scale
Standard Deviation 8.57
|
SECONDARY outcome
Timeframe: Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dosePopulation: Full Analysis Set (FAS):
Clinical Opiate Withdrawal Scale (COWS): The COWS scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated include resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety or irritability, and gooseflesh. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=24 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Peak COWS Score at Baseline and Over Time
Baseline (Pre-Dose, Day 6)
|
2.4 score on a scale
Standard Deviation 1.77
|
4.6 score on a scale
Standard Deviation 3.54
|
5.2 score on a scale
Standard Deviation 3.87
|
4.1 score on a scale
Standard Deviation 2.68
|
4.4 score on a scale
Standard Deviation 3.07
|
3.8 score on a scale
Standard Deviation 2.76
|
2.7 score on a scale
Standard Deviation 2.49
|
|
Peak COWS Score at Baseline and Over Time
Day 6 Post dose
|
4.2 score on a scale
Standard Deviation 2.77
|
6.7 score on a scale
Standard Deviation 3.16
|
4.6 score on a scale
Standard Deviation 2.28
|
4.1 score on a scale
Standard Deviation 2.56
|
5.4 score on a scale
Standard Deviation 3.17
|
6.7 score on a scale
Standard Deviation 3.83
|
5 score on a scale
Standard Deviation 2.83
|
|
Peak COWS Score at Baseline and Over Time
Day 7 Postdose
|
8.8 score on a scale
Standard Deviation 5.37
|
6.1 score on a scale
Standard Deviation 3.73
|
6.1 score on a scale
Standard Deviation 2.32
|
6.5 score on a scale
Standard Deviation 3.07
|
7.4 score on a scale
Standard Deviation 3.65
|
7.3 score on a scale
Standard Deviation 4.29
|
6.1 score on a scale
Standard Deviation 3.25
|
|
Peak COWS Score at Baseline and Over Time
Day 8 Postdose
|
8.9 score on a scale
Standard Deviation 5.54
|
4.3 score on a scale
Standard Deviation 3.4
|
6.1 score on a scale
Standard Deviation 3.93
|
4.8 score on a scale
Standard Deviation 2.86
|
6.8 score on a scale
Standard Deviation 3.64
|
6.0 score on a scale
Standard Deviation 4.29
|
5.9 score on a scale
Standard Deviation 3.61
|
|
Peak COWS Score at Baseline and Over Time
Day 9 Postdose
|
6.2 score on a scale
Standard Deviation 3.80
|
4.7 score on a scale
Standard Deviation 1.98
|
4.7 score on a scale
Standard Deviation 2.54
|
3.5 score on a scale
Standard Deviation 2.22
|
7.0 score on a scale
Standard Deviation 3.30
|
6.8 score on a scale
Standard Deviation 3.01
|
6.0 score on a scale
Standard Deviation 6.14
|
|
Peak COWS Score at Baseline and Over Time
Day 10 Postdose
|
4.9 score on a scale
Standard Deviation 3.67
|
3.5 score on a scale
Standard Deviation 1.52
|
3.7 score on a scale
Standard Deviation 2.56
|
3.5 score on a scale
Standard Deviation 2.07
|
4.6 score on a scale
Standard Deviation 1.91
|
3.8 score on a scale
Standard Deviation 1.47
|
3.9 score on a scale
Standard Deviation 2.17
|
|
Peak COWS Score at Baseline and Over Time
Day 11 Postdose
|
5.4 score on a scale
Standard Deviation 4.28
|
5.0 score on a scale
Standard Deviation 5.83
|
2.0 score on a scale
Standard Deviation 1.63
|
3.4 score on a scale
Standard Deviation 2.20
|
4.5 score on a scale
Standard Deviation 3.33
|
3.5 score on a scale
Standard Deviation 2.26
|
3.0 score on a scale
Standard Deviation 2.83
|
|
Peak COWS Score at Baseline and Over Time
Day 12 Postdose
|
3.6 score on a scale
Standard Deviation 2.07
|
4.6 score on a scale
Standard Deviation 4.28
|
2.0 score on a scale
Standard Deviation 1.10
|
2.4 score on a scale
Standard Deviation 1.77
|
3.6 score on a scale
Standard Deviation 2.46
|
3.3 score on a scale
Standard Deviation 1.75
|
4.5 score on a scale
Standard Deviation 4.76
|
|
Peak COWS Score at Baseline and Over Time
Day 13 Postdose
|
5.3 score on a scale
Standard Deviation 2.93
|
4.0 score on a scale
Standard Deviation 3.67
|
4.2 score on a scale
Standard Deviation 2.93
|
2.5 score on a scale
Standard Deviation 1.77
|
2.6 score on a scale
Standard Deviation 1.27
|
3.0 score on a scale
Standard Deviation 2.10
|
3.2 score on a scale
Standard Deviation 3.97
|
|
Peak COWS Score at Baseline and Over Time
Day 14 Postdose
|
3.4 score on a scale
Standard Deviation 1.99
|
3.2 score on a scale
Standard Deviation 2.17
|
2.8 score on a scale
Standard Deviation 2.32
|
1.4 score on a scale
Standard Deviation 1.62
|
2.3 score on a scale
Standard Deviation 1.37
|
3.3 score on a scale
Standard Deviation 2.42
|
3.5 score on a scale
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dosePopulation: Full Analysis Set (FAS)
Clinical Opiate Withdrawal Scale (COWS): The COWs scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated include resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety or irritability, and gooseflesh. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=24 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Average COWS Scores at Baseline and Over Time
Day 7 Post dose
|
6.19 score on a scale
Standard Deviation 4.013
|
5.63 score on a scale
Standard Deviation 3.562
|
4.92 score on a scale
Standard Deviation 2.390
|
5.08 score on a scale
Standard Deviation 2.849
|
6.41 score on a scale
Standard Deviation 3.205
|
6.04 score on a scale
Standard Deviation 4.109
|
4.54 score on a scale
Standard Deviation 2.349
|
|
Average COWS Scores at Baseline and Over Time
Day 8 Post dose
|
7.19 score on a scale
Standard Deviation 4.489
|
3.21 score on a scale
Standard Deviation 2.797
|
5.19 score on a scale
Standard Deviation 3.646
|
3.70 score on a scale
Standard Deviation 2.163
|
5.81 score on a scale
Standard Deviation 3.391
|
4.40 score on a scale
Standard Deviation 2.569
|
5.14 score on a scale
Standard Deviation 3.359
|
|
Average COWS Scores at Baseline and Over Time
Baseline (Pre-Dose, Day 6)
|
2.41 score on a scale
Standard Deviation 1.770
|
4.59 score on a scale
Standard Deviation 3.537
|
5.19 score on a scale
Standard Deviation 3.868
|
4.05 score on a scale
Standard Deviation 2.677
|
4.38 score on a scale
Standard Deviation 3.074
|
3.80 score on a scale
Standard Deviation 2.757
|
2.71 score on a scale
Standard Deviation 2.493
|
|
Average COWS Scores at Baseline and Over Time
Day 6, Post-Dose
|
3.21 score on a scale
Standard Deviation 1.913
|
5.22 score on a scale
Standard Deviation 3.173
|
3.85 score on a scale
Standard Deviation 2.254
|
3.26 score on a scale
Standard Deviation 2.287
|
4.29 score on a scale
Standard Deviation 2.853
|
4.83 score on a scale
Standard Deviation 2.814
|
4.02 score on a scale
Standard Deviation 2.477
|
|
Average COWS Scores at Baseline and Over Time
Day 9 Post dose
|
5.11 score on a scale
Standard Deviation 3.462
|
3.50 score on a scale
Standard Deviation 1.780
|
4.20 score on a scale
Standard Deviation 2.440
|
2.80 score on a scale
Standard Deviation 1.859
|
5.63 score on a scale
Standard Deviation 2.970
|
5.25 score on a scale
Standard Deviation 2.478
|
5.39 score on a scale
Standard Deviation 6.279
|
|
Average COWS Scores at Baseline and Over Time
Day 10 Post dose
|
3.43 score on a scale
Standard Deviation 2.992
|
3.17 score on a scale
Standard Deviation 1.693
|
3.07 score on a scale
Standard Deviation 2.110
|
2.70 score on a scale
Standard Deviation 1.884
|
3.82 score on a scale
Standard Deviation 1.647
|
2.67 score on a scale
Standard Deviation 1.252
|
2.81 score on a scale
Standard Deviation 1.731
|
|
Average COWS Scores at Baseline and Over Time
Day 11 Postdose
|
3.57 score on a scale
Standard Deviation 2.589
|
3.30 score on a scale
Standard Deviation 3.054
|
1.50 score on a scale
Standard Deviation 1.258
|
2.69 score on a scale
Standard Deviation 2.086
|
3.59 score on a scale
Standard Deviation 2.782
|
2.58 score on a scale
Standard Deviation 1.530
|
2.50 score on a scale
Standard Deviation 2.799
|
|
Average COWS Scores at Baseline and Over Time
Day 12 Post dose
|
3.07 score on a scale
Standard Deviation 2.263
|
3.30 score on a scale
Standard Deviation 2.864
|
1.42 score on a scale
Standard Deviation 1.068
|
1.81 score on a scale
Standard Deviation 1.438
|
3.14 score on a scale
Standard Deviation 2.521
|
2.58 score on a scale
Standard Deviation 1.715
|
3.58 score on a scale
Standard Deviation 4.364
|
|
Average COWS Scores at Baseline and Over Time
Day 13 Post dose
|
4.07 score on a scale
Standard Deviation 2.335
|
3.20 score on a scale
Standard Deviation 3.883
|
2.58 score on a scale
Standard Deviation 1.594
|
2.13 score on a scale
Standard Deviation 1.847
|
1.71 score on a scale
Standard Deviation 1.035
|
2.50 score on a scale
Standard Deviation 1.549
|
2.58 score on a scale
Standard Deviation 3.247
|
|
Average COWS Scores at Baseline and Over Time
Day 14 Post dose
|
3.43 score on a scale
Standard Deviation 1.988
|
2.70 score on a scale
Standard Deviation 1.924
|
1.92 score on a scale
Standard Deviation 1.201
|
1.21 score on a scale
Standard Deviation 1.468
|
2.33 score on a scale
Standard Deviation 1.366
|
3.00 score on a scale
Standard Deviation 1.897
|
3.33 score on a scale
Standard Deviation 3.204
|
SECONDARY outcome
Timeframe: Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dosePopulation: Full Analysis Set (FAS)
Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids.5 Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=24 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Average SOWS at Baseline and Over Time
Day 14 Postdose
|
2.43 score on a scale
Standard Deviation 2.637
|
2.40 score on a scale
Standard Deviation 3.362
|
1.67 score on a scale
Standard Deviation 2.251
|
1.71 score on a scale
Standard Deviation 2.270
|
1.67 score on a scale
Standard Deviation 2.338
|
1.08 score on a scale
Standard Deviation 1.686
|
2.92 score on a scale
Standard Deviation 6.216
|
|
Average SOWS at Baseline and Over Time
Baseline, Pre-Dose, Day 6
|
3.59 score on a scale
Standard Deviation 3.242
|
5.18 score on a scale
Standard Deviation 3.861
|
5.95 score on a scale
Standard Deviation 5.454
|
4.74 score on a scale
Standard Deviation 4.641
|
4.95 score on a scale
Standard Deviation 4.433
|
6.53 score on a scale
Standard Deviation 7.376
|
6.21 score on a scale
Standard Deviation 6.934
|
|
Average SOWS at Baseline and Over Time
Day 6 Postdose
|
3.35 score on a scale
Standard Deviation 3.071
|
7.13 score on a scale
Standard Deviation 6.617
|
5.88 score on a scale
Standard Deviation 3.916
|
5.79 score on a scale
Standard Deviation 4.388
|
6.81 score on a scale
Standard Deviation 5.815
|
8.50 score on a scale
Standard Deviation 4.935
|
6.58 score on a scale
Standard Deviation 6.780
|
|
Average SOWS at Baseline and Over Time
Day 7 Postdose
|
6.73 score on a scale
Standard Deviation 5.426
|
8.83 score on a scale
Standard Deviation 6.959
|
7.39 score on a scale
Standard Deviation 4.513
|
8.42 score on a scale
Standard Deviation 6.380
|
11.53 score on a scale
Standard Deviation 7.702
|
10.63 score on a scale
Standard Deviation 9.670
|
7.54 score on a scale
Standard Deviation 5.458
|
|
Average SOWS at Baseline and Over Time
Day 8 Postdose
|
8.65 score on a scale
Standard Deviation 7.967
|
4.86 score on a scale
Standard Deviation 4.616
|
7.63 score on a scale
Standard Deviation 5.614
|
6.85 score on a scale
Standard Deviation 5.991
|
9.31 score on a scale
Standard Deviation 7.765
|
10.15 score on a scale
Standard Deviation 8.267
|
7.92 score on a scale
Standard Deviation 6.828
|
|
Average SOWS at Baseline and Over Time
Day 9 Postdose
|
6.11 score on a scale
Standard Deviation 3.361
|
4.14 score on a scale
Standard Deviation 2.428
|
5.65 score on a scale
Standard Deviation 4.404
|
4.95 score on a scale
Standard Deviation 5.325
|
8.21 score on a scale
Standard Deviation 4.398
|
9.00 score on a scale
Standard Deviation 7.521
|
7.06 score on a scale
Standard Deviation 9.318
|
|
Average SOWS at Baseline and Over Time
Day 10 Postdose
|
4.79 score on a scale
Standard Deviation 4.030
|
3.33 score on a scale
Standard Deviation 2.206
|
4.57 score on a scale
Standard Deviation 4.457
|
3.50 score on a scale
Standard Deviation 5.217
|
6.59 score on a scale
Standard Deviation 3.740
|
5.08 score on a scale
Standard Deviation 2.178
|
3.06 score on a scale
Standard Deviation 3.076
|
|
Average SOWS at Baseline and Over Time
Day 11 Postdose
|
2.79 score on a scale
Standard Deviation 2.464
|
2.20 score on a scale
Standard Deviation 2.414
|
3.00 score on a scale
Standard Deviation 3.651
|
1.94 score on a scale
Standard Deviation 2.195
|
5.18 score on a scale
Standard Deviation 5.139
|
3.42 score on a scale
Standard Deviation 2.223
|
3.50 score on a scale
Standard Deviation 6.110
|
|
Average SOWS at Baseline and Over Time
Day 12 Postdose
|
4.00 score on a scale
Standard Deviation 4.252
|
2.20 score on a scale
Standard Deviation 2.168
|
2.00 score on a scale
Standard Deviation 2.387
|
2.19 score on a scale
Standard Deviation 3.294
|
4.77 score on a scale
Standard Deviation 4.967
|
3.67 score on a scale
Standard Deviation 2.696
|
4.58 score on a scale
Standard Deviation 6.953
|
|
Average SOWS at Baseline and Over Time
Day 13 Postdose
|
3.93 score on a scale
Standard Deviation 2.775
|
4.70 score on a scale
Standard Deviation 7.068
|
2.08 score on a scale
Standard Deviation 1.882
|
3.31 score on a scale
Standard Deviation 3.891
|
2.21 score on a scale
Standard Deviation 1.542
|
2.50 score on a scale
Standard Deviation 1.049
|
3.25 score on a scale
Standard Deviation 5.760
|
SECONDARY outcome
Timeframe: Day 6 through Day 14Population: Full Analysis Set (FAS)
Time to drop-out during double-blind treatment phase after discontinuation of opioid maintenance Phase.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=25 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Time to Drop-out After Discontinuation of Opioid Maintenance Phase
|
3.1 Days
Interval 0.7 to
The upper limit is not estimable due to the limitations imposed by the small sample size
|
1.5 Days
Interval 0.0 to
The upper limit is not estimable due to the limitations imposed by the small sample size
|
3.1 Days
Interval 2.2 to 6.0
|
5.1 Days
Interval 1.1 to
The upper limit is not estimable due to the limitations imposed by the small sample size
|
6.1 Days
Interval 2.1 to
The upper limit is not estimable due to the limitations imposed by the small sample size
|
3.5 Days
Interval 1.0 to
The upper limit is not estimable due to the limitations imposed by the small sample size
|
2.0 Days
Interval 0.7 to 5.1
|
SECONDARY outcome
Timeframe: Day 6 through Day 14Population: Full Analysis Set (FAS)
Number and Percentage of Subject Drop-out after Discontinuation of Opioid Maintenance Phase Within Each Treatment Group Between Days 6-14.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=25 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 6
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 7
|
1 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 8
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 9
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 10
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 11
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 13
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-Dose Day 6 to Day 12Population: Full Analysis Set (FAS)
Overall Agitation-Calmness Evaluation Scale (ACES): The ACES scale is a single-item measure rating overall agitation and sedation, ranging from 1 (marked agitation) to 9 (unarousable). This outcome measures the total ACES total score over time at 2 hours, post-first dose.
Outcome measures
| Measure |
30 Micrograms
n=17 Participants
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=16 Participants
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=20 Participants
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 Participants
Sublingual film containing 240 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=25 Participants
Sublingual film containing Placebo
Comparator: Placebo Sublingual Film
|
|---|---|---|---|---|---|---|---|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 12, Post-Dose
|
4.3 units on a scale
Standard Deviation 0.76
|
4.4 units on a scale
Standard Deviation 1.4
|
4.7 units on a scale
Standard Deviation 1.21
|
4.0 units on a scale
Standard Deviation 0.00
|
4.1 units on a scale
Standard Deviation 0.83
|
4.8 units on a scale
Standard Deviation 1.33
|
4.0 units on a scale
Standard Deviation 1.10
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 6, Post-Dose
|
4.6 units on a scale
Standard Deviation 1.27
|
3.4 units on a scale
Standard Deviation 1.71
|
4.4 units on a scale
Standard Deviation 1.35
|
4.9 units on a scale
Standard Deviation 1.31
|
4.7 units on a scale
Standard Deviation 1.35
|
4.9 units on a scale
Standard Deviation 1.73
|
4.3 units on a scale
Standard Deviation 1.40
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 7, Post-Dose
|
4.3 units on a scale
Standard Deviation 0.95
|
3.6 units on a scale
Standard Deviation 1.83
|
3.8 units on a scale
Standard Deviation 1.29
|
3.9 units on a scale
Standard Deviation 0.76
|
4.1 units on a scale
Standard Deviation 1.48
|
4.4 units on a scale
Standard Deviation 1.73
|
4.1 units on a scale
Standard Deviation 0.86
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 8, Post-Dose
|
3.8 units on a scale
Standard Deviation 1.17
|
4.1 units on a scale
Standard Deviation 1.07
|
4.0 units on a scale
Standard Deviation 1.26
|
4.6 units on a scale
Standard Deviation 1.43
|
4.2 units on a scale
Standard Deviation 1.17
|
5.0 units on a scale
Standard Deviation 1.83
|
4.1 units on a scale
Standard Deviation 0.83
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 9, Post-Dose
|
3.0 units on a scale
Standard Deviation 0.87
|
4.1 units on a scale
Standard Deviation 1.46
|
3.7 units on a scale
Standard Deviation 0.67
|
4.5 units on a scale
Standard Deviation 1.18
|
3.5 units on a scale
Standard Deviation 0.80
|
4.7 units on a scale
Standard Deviation 2.06
|
3.8 units on a scale
Standard Deviation 0.46
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 10, Post-Dose
|
4.1 units on a scale
Standard Deviation 1.77
|
3.8 units on a scale
Standard Deviation 0.98
|
4.1 units on a scale
Standard Deviation 0.38
|
4.3 units on a scale
Standard Deviation 1.06
|
4.3 units on a scale
Standard Deviation 1.01
|
4.3 units on a scale
Standard Deviation 1.37
|
4.4 units on a scale
Standard Deviation 0.92
|
|
Total ACES Total Score Over Time - 2 hr. Post-First Dose
Day 11, Post-Dose
|
4.7 units on a scale
Standard Deviation 1.50
|
4.0 units on a scale
Standard Deviation 0.71
|
4.1 units on a scale
Standard Deviation 0.38
|
4.1 units on a scale
Standard Deviation 0.64
|
3.9 units on a scale
Standard Deviation 0.94
|
4.2 units on a scale
Standard Deviation 0.41
|
4.6 units on a scale
Standard Deviation 1.13
|
Adverse Events
30 Micrograms
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
60 Micrograms
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
90 Micrograms
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
120 Micrograms
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
180 Micrograms
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
240 Micrograms
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30 Micrograms
n=17 participants at risk
Sublingual film containing 30 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
60 Micrograms
n=17 participants at risk
Sublingual film containing 60 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
90 Micrograms
n=21 participants at risk
Sublingual film containing 90 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
120 Micrograms
n=19 participants at risk
Sublingual film containing 120 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
180 Micrograms
n=21 participants at risk
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
240 Micrograms
n=15 participants at risk
Sublingual film containing 180 Micrograms Dexmedetomidine
Dexmedetomidine (BXCL501): Sublingual Film
|
Pooled Placebo
n=25 participants at risk
Sublingual film containing Placebo
Placebo: Sublingual Placebo film
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
11.8%
2/17 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
12.0%
3/25 • Number of events 3 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.9%
1/17 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
9.5%
2/21 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.0%
1/25 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.9%
1/17 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
20.0%
3/15 • Number of events 3 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
General disorders
Chills
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
General disorders
Fatigue
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Infections and infestations
Furnucle
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
6.7%
1/15 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
9.5%
2/21 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
46.7%
7/15 • Number of events 7 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
11.8%
2/17 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
11.8%
2/17 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.8%
1/21 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.3%
1/19 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
14.3%
3/21 • Number of events 3 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/15 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
4.0%
1/25 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
5.9%
1/17 • Number of events 1 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
33.3%
5/15 • Number of events 5 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/17 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/21 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/19 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
9.5%
2/21 • Number of events 2 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
26.7%
4/15 • Number of events 4 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
0.00%
0/25 • 9 days
The number of subjects that experienced at least one Treatment Emergent Adverse Event (TEAE) during the double-blind randomized Phase. Treatment-Emergent Adverse Events (TEAEs) were exclusively documented during the double-blind Phase, aiming to evaluate the safety profile of BXCL501 in the context of opioid withdrawal subsequent to the cessation of oral morphine.
|
Additional Information
Vice President Head of Clinical Operations
Bioxcel Therapeutics
Phone: (475) 355 5177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place