Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal 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 clearly with the Investigator and staff.
You may not be if
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 at the site of surgery.
Female subjects who are pregnant or breastfeeding.
Diagnosis of chronic pain and ongoing or frequent use of pain medications.
Clareo Health | Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy