A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.

Timeline

Start

2021-08-30

Primary completion

2021-12-05

Completion

2021-12-21

Outcome

Met primary endpoint

paper 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. PMID 37530822 ↗

release “Treatment with the NaV1.8 inhibitor VX-548 met the primary endpoint in both Phase 2 proof-of-concept acute pain studies following abdominoplasty or bunionectomy surgery” vrtx.com ↗

Publications

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	325 mg	Oral
Comparator	Hydrocodone bitartrate	Unknown	5 mg	Oral
Subject	Suzetrigine	Small molecule	30 mg	Oral
Subject	Suzetrigine	Small molecule	50 mg	Oral

Indications

No indication recorded.