CPL-01 in the Management of Postoperative Pain After Bunionectomy

Inclusion Criteria: * Ability to sign ICF * Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * BMI ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant over the study * If biologically male, either sterile or using acceptable form of birth control * Be willing and able to complete study procedures Exclusion Criteria: * Has previously undergone unilateral simple bunionectomy. * Has a planned concurrent surgical procedure * Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments * Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments. * Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Has history or evidence of impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN). * Has a history of malignancy in the past year * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months