Phase 2
N=274
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT04977336 ↗Enrolled (actual)
274
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug — 100.98; 115.64; 112.92; 86.87 units on a scale — p=0.3706
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VX-548 (Drug); HB/APAP (Drug); Placebo (matched to VX-548) (Drug); Placebo (matched to HB/APAP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug |
100.98; 115.64; 112.92; 86.87; 137.77 | 0.3706 |
| SECONDARY Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug |
31.54; 40.95; 34.36; 24.78; 45.22 | 0.2318 |
| SECONDARY Percentage of Participants With at Least 30 Percent (%) Reduction in NPRS at 48 Hours After the First Dose of Study Drug |
67.8; 68.3; 75.8; 62.9; 83.3 | 0.9986 |
| SECONDARY Percentage of Participants With at Least 50% Reduction in NPRS at 48 Hours After the First Dose of Study Drug |
61.0; 61.7; 72.7; 56.5; 66.7 | 0.9895 |
| SECONDARY Percentage of Participants With at Least 70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug |
40.7; 50.0; 51.5; 38.7; 51.7 | 0.3158 |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite) |
0.119; 0.311; 0.523; 0.118; 0.337; 0.503 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite) |
2.20; 2.17; 2.09; 1.93; 1.97; 2.00 | — |
| SECONDARY Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite) |
0.650; 1.84; 2.95; 0.885; 2.54; 3.72 | — |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
23; 25; 7; 17; 18; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.
Eligibility Criteria
Key Inclusion Criteria
- Before Surgery:
- Participant 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 other foot surgery on the index foot
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug
- After Surgery:
- Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications 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 (NCT04977336). 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.