Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

Inclusion Criteria:

• Men and women must be at least 18 years of age. Female subjects must meet additionalcriteria in relation to childbearing potential.

• Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy andinternal fixation (Austin bunionectomy) without collateral procedures.

• Subjects must have the ability to provide written informed consent.

• Subjects must have the ability to understand study procedures and communicate clearlywith the Investigator and staff.

Key Exclusion Criteria:

• Subjects undergoing emergency or unplanned surgery.

• Subjects who had any previous bunionectomy procedure on either foot.

• Subjects with pre-existing conditions (other than bunion) causing preoperative pain atthe site of surgery.

• Female subjects who are pregnant or breastfeeding.

• Diagnosis of chronic pain and ongoing or frequent use of pain medications.