PainReform Ltd. announced positive safety results 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. PRF-110 was administrated intra-operatively to validate the lead formulation's safety further and confirm optimal product instillation in the surgical wound. The initial results demonstrated a solid safety profile of PRF-110.

Twenty-six adverse events (AEs) were recorded in total, with no serious adverse events (SAEs) reported. All adverse events were considered mild, and most were deemed unlikely to be related to PRF-110. The optimal method of placing the product – “instillation,” was studied and locked as the method of choice.

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 forthcoming second part of the trial will be a double-blind study, in which the Company plans to randomize approximately 400 patients at seven clinical sites in the U.S. PRF-110 will be administered intra-operatively, using the experience gained in the study's first part, and will be divided into three cohorts, PRF-110, ropivacaine, and placebo in a 2:2:1 ratio.

As previously reported, PRF-110 provided pain reduction for up to 72 hours post-operatively in the Company's prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair). PRF-110 is a highly uniform solution, resulting in consistent sustained and extended release of the analgesic. Ropivacaine, the active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic.

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 that are common in drug development.