Selective Inhibition of Na V 1.8 with VX-548 for Acute Pain
Authors' conclusion
As compared with placebo, VX-548 at the highest dose, but not at lower doses, reduced acute pain over a period of 48 hours after abdominoplasty or bunionectomy. VX-548 was associated with adverse events that were mild to moderate in severity.
Study context
- Population
- Participants with acute pain after abdominoplasty or bunionectomy303 abdominoplasty, 274 bunionectomy
- Comparison
- VX-548 vs placebo; hydrocodone bitartrate-acetaminophen as reference
- Primary endpoint
- Time-weighted sum of the pain-intensity difference (SPID48), from NRS (0–10; higher = greater pain) at 19 time points
- Follow-up
- 48 hours
Methodological detailsplacebo-controlled, active comparator (hydrocodone bitartrate-acetaminophen), in vitro selectivity study
- Placebo-controlled
- Active comparator (hydrocodone bitartrate-acetaminophen)
- In vitro selectivity study
Primary result
As reported in the abstract
Time-weighted SPID48
High-dose VX-548 vs PlaceboLeast-squares mean difference (95% CI)
Abdominoplasty trial
37.8(9.2–66.4)
Bunionectomy trial
36.8(4.6–69.0)
Safety
- Headache and constipation common with VX-548; adverse events mild to moderate
Original publication
Selective Inhibition of Na V 1.8 with VX-548 for Acute Pain. N Engl J Med. Published 3 August 2023. doi:10.
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