Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Key Inclusion Criteria:

- Before Surgery

- Participants 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 or other foot surgery on the index foot; or
bunionectomy on the opposite foot

- History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia
treatment(s)

- Any prior surgery within 1 month before the first study drug dose

- After Surgery

- Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant
surgery such as hammertoe repair; or experienced medical complications during the
bunionectomy

- Participant had a medical complication during the bunionectomy that, in the
opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.