A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

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 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) within the last 2 years
• A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

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

Other protocol defined inclusion/exclusion criteria may apply.