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A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

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Trial Profile

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs Suzetrigine (Primary) ; Hydrocodone/paracetamol
  • Indications Acute pain
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 03 Aug 2023 According to a Vertex Pharmaceuticals media release, the company announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase 2 proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty and bunionectomy surgeries.
  • 03 Aug 2023 Results from two clinical trials (NCT04977336 and NCT05034952) assessing acute pain over a period of 48 hours after abdominoplasty or bunionectomy published in the New England Journal of Medicine
  • 22 Jul 2022 According to a Vertex Pharmaceuticals media release, VX-548 was granted breakthrough Therapy Designation based on data from the phase 2 proof-of-concept studies.

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