Phase 3
Completed N=1,118
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
Source: ClinicalTrials.gov NCT05558410 ↗Enrolled (actual)
1,118
Serious AEs
2.1%
Results posted
Jul 2025
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
▲ Trending
1citation · ~1 / year
The Clinical Application of Suzetrigine.
Summary
The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.
Linked Publications
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The Clinical Application of Suzetrigine.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.