PainReform Ltd. announced positive pharmacokinetic (PK) data in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax). Cmax value among all of the 15 patients, was approximately 10% of the safety window set by FDA.

The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia. The other components that make up the remainder of the PRF-110 formulation have been designated by the FDA as Generally Recognized as Safe (GRAS), by the FDA, mitigating many potential safety issues.