Phase 3
N=1,118
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT05558410 ↗Enrolled (actual)
1,118
Serious AEs
2.1%
Results posted
Jul 2025
Primary outcome: Primary: 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; 118.4 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Suzetrigine (SUZ) (Drug); HB/APAP (Drug); Placebo (matched to SUZ) (Drug); Placebo (matched to HB/APAP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 118.4 | <0.0001 sig |
| SECONDARY 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; 118.4 | 0.2781 |
| SECONDARY Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo |
480; 119 | <0.0001 sig |
| SECONDARY Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo |
91; 34 | <0.0001 sig |
| SECONDARY Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo |
49.8; 67.8 | <0.0001 sig |
| SECONDARY Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP |
33.5; 20.3 | <0.0001 sig |
| SECONDARY Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo |
24.2; 48.0 | <0.0001 sig |
| SECONDARY Time to First Use of Rescue Medication, SUZ Compared to Placebo |
115; 186 | <0.0001 sig |
| SECONDARY Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo |
87.9; 81.0 | 0.0237 sig |
| SECONDARY Total Rescue Medication Usage, SUZ Compared to Placebo |
1200; 800 | 0.0080 sig |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
125; 272; 224; 5; 7; 11 | — |
Summary
The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.
Eligibility Criteria
Key Inclusion Criteria
- Before Surgery
- Participant scheduled to undergo a standard ("full") abdominoplasty procedure
- After Surgery
- Participant is lucid and able to follow commands and able to swallow oral medications
- All analgesic guidelines were followed during and after the abdominoplasty
- Abdominoplasty procedure duration less than or equal to (≤3) hours
Key Exclusion Criteria
- Before Surgery
- Prior history of abdominoplasty
- History of Intra-abdominal and/or pelvic surgery that resulted into complications
- History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug dose
- After Surgery
- Participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
- Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05558410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.