Phase 3
N=1,075
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT05553366 ↗Enrolled (actual)
1,075
Serious AEs
0.0%
Results posted
Aug 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 — 70.6; 99.9 units on a scale — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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
- Dec 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 |
70.6; 99.9 | 0.0002 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 |
120.1; 99.9 | 0.0016 sig |
| SECONDARY Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo |
480; 240 | 0.0016 sig |
| SECONDARY Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo |
61; 60 | 0.1315 |
| SECONDARY Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo |
53.2; 61.7 | 0.0343 sig |
| SECONDARY Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP |
16.5; 9.2 | 0.0014 sig |
| SECONDARY Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo |
19.8; 30.6 | 0.0032 sig |
| SECONDARY Time to First Use of Rescue Medication, SUZ Compared to Placebo |
185; 157 | 0.8592 |
| SECONDARY Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo |
85.6; 85.4 | 0.9143 |
| SECONDARY Total Rescue Medication Usage, SUZ Compared to Placebo |
800; 800 | 0.0205 sig |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
76; 180; 132; 0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.
Eligibility Criteria
Key Inclusion Criteria
- Before Surgery
- Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
- After Surgery
- Participant is lucid and able to follow commands
- All analgesic guidelines were followed during and after the bunionectomy
Key Exclusion Criteria
- Before Surgery
- Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
- 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 type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
- Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05553366). 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.