A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
This study will evaluate the dose-response relationship and safety of VX-150 in treating
 acute pain following bunionectomy.
Key Inclusion Criteria:

 Before surgery:

 -  Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)

 -  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 greater than or equal to (>=) 4 on Numeric Pain Rating Scale
 (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

 Key Exclusion Criteria:

 Before 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 on the index foot

 -  History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

 After surgery:

 -  Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

 Other protocol defined inclusion/exclusion criteria may apply