Trial Outcomes & Findings for Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence (NCT NCT01903005)
NCT ID: NCT01903005
Last Updated: 2015-10-28
Results Overview
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
668 participants
Primary outcome timeframe
Day 1 through week 24
Results posted on
2015-10-28
Participant Flow
A total of 668 patients who completed primary study OX219-006 (NCT01908842) or OX219-007 (NCT01848054) were enrolled. Three patients entered the study without taking any study medication and were excluded. A total of 665 patients were included in the data analyses.
Participant milestones
| Measure |
Safety Population
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Overall Study
STARTED
|
665
|
|
Overall Study
COMPLETED
|
292
|
|
Overall Study
NOT COMPLETED
|
373
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Baseline characteristics by cohort
| Measure |
OX219-006 Completers
n=475 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
OX219-007 Completers
n=190 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
Total
n=665 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
410 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
402 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Height
|
171.99 cm
STANDARD_DEVIATION 9.43 • n=5 Participants
|
173.35 cm
STANDARD_DEVIATION 10.01 • n=7 Participants
|
172.38 cm
STANDARD_DEVIATION 9.61 • n=5 Participants
|
|
Weight
|
78.34 kg
STANDARD_DEVIATION 18.99 • n=5 Participants
|
78.98 kg
STANDARD_DEVIATION 20.73 • n=7 Participants
|
78.53 kg
STANDARD_DEVIATION 19.49 • n=5 Participants
|
|
Body Mass Index
|
26.47 kg/m^2
STANDARD_DEVIATION 6.11 • n=5 Participants
|
26.26 kg/m^2
STANDARD_DEVIATION 6.63 • n=7 Participants
|
26.41 kg/m^2
STANDARD_DEVIATION 6.26 • n=5 Participants
|
|
Duration of Opioid Use
|
7.20 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 8.79 • n=7 Participants
|
7.95 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through week 24Population: Safety population
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Number of Patients Reporting Treatment-Emergent Adverse Events
Constipation
|
20 participants
|
|
Number of Patients Reporting Treatment-Emergent Adverse Events
Headache
|
21 participants
|
PRIMARY outcome
Timeframe: Day 1 through week 24Population: Safety population
Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
Gastrointestinal disorders
|
32 participants
|
|
Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
Constipation
|
19 participants
|
PRIMARY outcome
Timeframe: Day 1 throught week 24Population: Safety population
Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Possibly treatment-related
|
1 participants
|
|
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Not treatment-related
|
8 participants
|
PRIMARY outcome
Timeframe: Day 1 through week 24Population: Safety population
Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
|
14 participants
|
SECONDARY outcome
Timeframe: Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24Population: Safety population
Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Retention in Treatment in the Safety Population
Week 4
|
563 participants
Interval 545.0 to 581.0
|
|
Retention in Treatment in the Safety Population
Week 8
|
483 participants
Interval 460.0 to 505.0
|
|
Retention in Treatment in the Safety Population
Week 12
|
425 participants
Interval 401.0 to 450.0
|
|
Retention in Treatment in the Safety Population
Week 16
|
383 participants
Interval 358.0 to 408.0
|
|
Retention in Treatment in the Safety Population
Week 20
|
333 participants
Interval 308.0 to 358.0
|
|
Retention in Treatment in the Safety Population
Week 24
|
292 participants
Interval 267.0 to 317.0
|
SECONDARY outcome
Timeframe: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpointPopulation: Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data
Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 4 (n=557)
|
-12.2 units on a scale
Interval -12.6 to -11.8
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 8 (n=477)
|
-12.7 units on a scale
Interval -13.1 to -12.3
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 12 (n=423)
|
-12.9 units on a scale
Interval -13.4 to -12.5
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 16 (n=384)
|
-13.1 units on a scale
Interval -13.6 to -12.6
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 20 (n=336)
|
-13.3 units on a scale
Interval -13.8 to -12.8
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Week 24 (completers only; n=288)
|
-13.1 units on a scale
Interval -13.7 to -12.6
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Study Endpoint (n=597)
|
-12.5 units on a scale
Interval -12.9 to -12.1
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
Day 1 (n=658)
|
-12.0 units on a scale
Interval -12.3 to -11.6
|
SECONDARY outcome
Timeframe: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpointPopulation: Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data
Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Day 1 (n=650)
|
-26.8 units on a scale
Interval -27.8 to -25.7
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 4 (n=550)
|
-27.4 units on a scale
Interval -28.6 to -26.2
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 8 (n=472)
|
-28.0 units on a scale
Interval -29.2 to -26.7
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 12 (n=418)
|
-27.7 units on a scale
Interval -29.0 to -26.3
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 16 (n=376)
|
-28.7 units on a scale
Interval -30.1 to -27.3
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 20 (n=331)
|
-28.9 units on a scale
Interval -30.4 to -27.5
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Week 24 (n=282)
|
-27.7 units on a scale
Interval -29.4 to -26.0
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
Study Endpoint (n=588)
|
-27.3 units on a scale
Interval -28.5 to -26.1
|
SECONDARY outcome
Timeframe: Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpointPopulation: Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data
Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Day 1 (n=646)
|
-52.8 units on a scale
Interval -55.0 to -50.6
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 4 (n=563)
|
-56.6 units on a scale
Interval -59.0 to -54.2
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 8 (n=479)
|
-59.4 units on a scale
Interval -62.0 to -56.9
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 12 (n=426)
|
-59.4 units on a scale
Interval -62.0 to -56.8
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 16 (n=384)
|
-61.5 units on a scale
Interval -64.1 to -58.8
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 20 (n=338)
|
-61.4 units on a scale
Interval -64.3 to -58.5
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Week 24 (n=289)
|
-60.5 units on a scale
Interval -63.8 to -57.2
|
|
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Study Endpoint (n=598)
|
-57.3 units on a scale
Interval -59.6 to -55.0
|
SECONDARY outcome
Timeframe: Study EndpointPopulation: Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed
Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)
Unemployed at baseline; employed at study endpoint
|
21.3 percentage of patients
|
|
Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)
Employed at baseline; unemployed at study endpoint
|
6.0 percentage of patients
|
|
Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)
Increase in patients employed at study endpoint
|
15.3 percentage of patients
|
SECONDARY outcome
Timeframe: Week 24Population: Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed
Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Missed work hours due to opioid dependence (n=79)
|
-4.8 hours
Interval -8.1 to -1.5
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Missed work hours due to other reason (n=79)
|
-0.2 hours
Interval -1.9 to 1.5
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Number of hours actually worked (n=78)
|
7.7 hours
Interval 3.4 to 12.0
|
SECONDARY outcome
Timeframe: Week 24Population: Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed
Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)
Outcome measures
| Measure |
Safety Population
n=665 Participants
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
Problem affects work productivity (n=70)
|
-3.9 units on a scale
Interval -4.7 to -3.1
|
|
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
Problem affects daily activities (n=283)
|
-4.3 units on a scale
Interval -4.8 to -3.9
|
Adverse Events
Safety Population
Serious events: 15 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=665 participants at risk
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Injury, poisoning and procedural complications
Heroin toxicity
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Cardiac disorders
Hypertensive and atherosclerotic cardiovascular disease
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Psychiatric disorders
Depression
|
0.30%
2/665 • Number of events 2 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Infections and infestations
Anal abscess
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Infections and infestations
Urinary tract infection
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Social circumstances
Intentional overdose
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Psychiatric disorders
Worsening of opioid dependence
|
0.30%
2/665 • Number of events 2 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Psychiatric disorders
Bipolar depression
|
0.15%
1/665 • Number of events 1 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
Other adverse events
| Measure |
Safety Population
n=665 participants at risk
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.0%
20/665 • Number of events 22 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
|
Nervous system disorders
Headache
|
3.2%
21/665 • Number of events 22 • Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place