A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

Inclusion Criteria:

Prior to Surgery:

- Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive

- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair,
without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic
block) not to include base wedge procedure

After Surgery:

- Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal
Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic
block on Day 1

- Subject is lucid and able to follow commands

- All analgesic guidelines were followed during and after the bunionectomy

Exclusion Criteria:

Prior to Surgery:

- History in the past 10 years of malignancy, except for squamous cell skin cancer,
basal cell skin cancer, and Stage 0 cervical carcinoma in situ

- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

- History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)

- History of peripheral neuropathy

- A known or clinically suspected infection with human immunodeficiency virus or
hepatitis B or C viruses

- Prior medical history of bunionectomy or other foot surgery

- Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen

- For female subjects: Pregnant, nursing, or planning to become pregnant during the
study or within 90 days after the last study drug dose

- For male subjects: Male subjects with a female partner who is pregnant, nursing, or
planning to become pregnant during the study or within 90 days after the last study
drug dose

After Surgery:

- Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery
such as hammertoe repair; or experienced medical complications during the bunionectomy
that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply.