Phase 3
N=258
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT05661734 ↗Enrolled (actual)
258
Serious AEs
0.8%
Results posted
Jul 2025
Primary outcome: Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 94; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Suzetrigine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
94; 2 | — |
| SECONDARY Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale |
83.2 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.
Eligibility Criteria
Key Inclusion Criteria
- Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
- Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS)
- Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS
Key Exclusion Criteria
- Surgical participants:
- History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed
- History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05661734). 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.