Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty (NCT NCT05558410)
NCT ID: NCT05558410
Last Updated: 2025-07-01
Results Overview
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
COMPLETED
PHASE3
1118 participants
0 to 48 hours After First Dose of Study Drug
2025-07-01
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
223
|
448
|
447
|
|
Overall Study
Safety Set
|
222
|
448
|
448
|
|
Overall Study
COMPLETED
|
206
|
426
|
423
|
|
Overall Study
NOT COMPLETED
|
17
|
22
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 48 hours.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
3
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
17
|
19
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Other non-compliance
|
0
|
1
|
2
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
1
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
Baseline characteristics by cohort
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
n=448 Participants
Participants received HB 5 mg/ APAP 325 mg q6h for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Total
n=1118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
441 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
1098 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
73 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
380 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
735 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
155 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
778 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
62 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 48 hours After First Dose of Study DrugPopulation: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) SUZ Compared to Placebo
|
70.1 units on a scale
Standard Error 6.1
|
118.4 units on a scale
Standard Error 4.3
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 hours After First Dose of Study DrugPopulation: FAS.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Outcome measures
| Measure |
Placebo
n=448 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) SUZ Compared to HB/APAP
|
111.8 units on a scale
Standard Error 4.3
|
118.4 units on a scale
Standard Error 4.3
|
—
|
SECONDARY outcome
Timeframe: From Baseline Up to 48 Hours After First Dose of Study DrugPopulation: FAS.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline. Participants who did not reach at least a 2-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo
|
480 minutes
Interval 477.0 to 705.0
|
119 minutes
Interval 90.0 to 180.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline Up to 48 Hours After First Dose of Study DrugPopulation: FAS.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS scores from baseline. Participants who did not reach at least a 1-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo
|
91 minutes
Interval 60.0 to 180.0
|
34 minutes
Interval 32.0 to 55.0
|
—
|
SECONDARY outcome
Timeframe: At 48 hoursPopulation: FAS.
The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported. Participants who discontinued study drug or had missing PGA at 48 hours were considered to not have reported good or excellent on the PGA.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo
|
49.8 percentage of participants
|
67.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline Up to Day 19Population: Safety set included all participants who received at least 1 dose of study drug.
The incidence with the events of vomiting or nausea during the specified time frame was reported.
Outcome measures
| Measure |
Placebo
n=448 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=448 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP
|
33.5 percentage of participants
|
20.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 Hours After First Dose of Study DrugPopulation: FAS.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference (PID) was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (NPRS range: 0 = no pain to 10 = worst possible pain). Time-weighted SPID was calculated as the sum of the PIDs at each post-dose time point multiplied by the time interval (in hours) between each time point. SPID 24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo
|
24.2 units on a scale
Standard Error 2.8
|
48.0 units on a scale
Standard Error 2.0
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS.
Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. Participants who did not take any rescue medication within 48 hours were censored at 48 hours.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Time to First Use of Rescue Medication, SUZ Compared to Placebo
|
115 minutes
Interval 100.0 to 132.0
|
186 minutes
Interval 158.0 to 212.0
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo
|
87.9 percentage of participants
|
81.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS.
Outcome measures
| Measure |
Placebo
n=223 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=447 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Total Rescue Medication Usage, SUZ Compared to Placebo
|
1200 milligram
Interval 0.0 to 3200.0
|
800 milligram
Interval 0.0 to 3200.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 19Population: Safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=222 Participants
Participants received placebo matched to SUZ and HB/APAP for 48 hours.
|
Suzetrigine (SUZ)
n=448 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
Suzetrigine (SUZ)
n=448 Participants
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
125 Participants
|
272 Participants
|
224 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
5 Participants
|
7 Participants
|
11 Participants
|
Adverse Events
Placebo
HB/APAP
Suzetrigine (SUZ)
Serious adverse events
| Measure |
Placebo
n=222 participants at risk
Participants received Placebo matched to SUZ and HB/APAP for 48 hours.
|
HB/APAP
n=448 participants at risk
Participants received HB 5 mg/ APAP 325 mg q6h for 48 hours.
|
Suzetrigine (SUZ)
n=448 participants at risk
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.45%
1/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Cardiac disorders
Cardiogenic shock
|
0.45%
1/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/222 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/222 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
General disorders
Impaired healing
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Immune system disorders
Drug hypersensitivity
|
0.45%
1/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Infections and infestations
Infected seroma
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Infections and infestations
Pneumonia
|
0.00%
0/222 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/222 • Day 1 up to Day 19
|
0.45%
2/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.90%
2/222 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
0.45%
2/448 • Day 1 up to Day 19
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.45%
1/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
|
Nervous system disorders
Syncope
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.22%
1/448 • Day 1 up to Day 19
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
1/222 • Day 1 up to Day 19
|
0.45%
2/448 • Day 1 up to Day 19
|
0.45%
2/448 • Day 1 up to Day 19
|
|
Vascular disorders
Hypotension
|
0.45%
1/222 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
0.00%
0/448 • Day 1 up to Day 19
|
Other adverse events
| Measure |
Placebo
n=222 participants at risk
Participants received Placebo matched to SUZ and HB/APAP for 48 hours.
|
HB/APAP
n=448 participants at risk
Participants received HB 5 mg/ APAP 325 mg q6h for 48 hours.
|
Suzetrigine (SUZ)
n=448 participants at risk
Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.8%
24/222 • Day 1 up to Day 19
|
8.7%
39/448 • Day 1 up to Day 19
|
10.5%
47/448 • Day 1 up to Day 19
|
|
Gastrointestinal disorders
Nausea
|
25.2%
56/222 • Day 1 up to Day 19
|
32.8%
147/448 • Day 1 up to Day 19
|
19.0%
85/448 • Day 1 up to Day 19
|
|
Nervous system disorders
Dizziness
|
7.7%
17/222 • Day 1 up to Day 19
|
5.4%
24/448 • Day 1 up to Day 19
|
4.0%
18/448 • Day 1 up to Day 19
|
|
Nervous system disorders
Headache
|
5.0%
11/222 • Day 1 up to Day 19
|
7.1%
32/448 • Day 1 up to Day 19
|
4.2%
19/448 • Day 1 up to Day 19
|
|
Vascular disorders
Hypotension
|
6.8%
15/222 • Day 1 up to Day 19
|
3.6%
16/448 • Day 1 up to Day 19
|
2.5%
11/448 • Day 1 up to Day 19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place