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 distalfirst metatarsal osteotomy (i.e., Austin procedure) and internal fixation underregional 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; orbunionectomy on the opposite foot

• History of cardiac dysrhythmias within the last 2 years requiringanti-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 medicalcomplications during the bunionectomy

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

Other protocol defined Inclusion/Exclusion criteria may apply.