Efficacy, Safety, and Pharmacokinetics of CPL-01, an Investigational Long-Acting Ropivacaine, in Bunionectomy: Results of a Phase 2b Study

CPL-01 (ropivacaine extended-release injection) is formulated to safely provide postoperative analgesia and reduce opioid use. Participants undergoing unilateral distal first metatarsal bunionectomy with osteotomy were randomized to receive either CPL-01 (200 mg in Cohort 1, 300 mg in Cohort 2), ropivacaine HCl (50 mg in Cohort 1, 75 mg in Cohort 2), or volume-matched placebo into the surgical site prior to closure. Participants remained in an inpatient setting for 72 hours to assess efficacy (Numeric Rating Scale [NRS] scores for pain with activity adjusted for opioid usage and rescue medication usage), safety and pharmacokinetics. Seventy-three participants were randomized and treated, and 71 participants completed the study. Participants who received 300 mg CPL-01 had a mean (SD) area under the curve from 0 to 72 hours (AUC