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 withosteotomy and internal fixation under regional anesthesia, without collateralprocedures 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 thestudy period or may confound postsurgical pain assessments

• Has a history or clinical manifestation of significant medical, neuropsychiatric, orother condition that could preclude or impair study participation or interfere withstudy assessments.

• Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenasedeficiency.

• Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), activehepatic 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 withinthe previous 6 months