A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

Inclusion Criteria: 1. Able and willing to provide written informed consent. 2. Male or female aged 18 years or older (inclusive). 3. Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia. 4. ASA Physical Status Classification of 1 or 2. 5. Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence. 6. Female subjects are elig…