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PainReform Completes First Part of Phase 3 Clinical Trial in Patients Undergoing Bunionectomy Surgery
First 15 patients administered PRF-110 intra-operatively TEL AVIV, Israel, March 28, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or
About this update from Prf Technologies Ltd.
[{"type":"text","content":"First 15 patients administered PRF-110 intra-operatively\nTEL AVIV, Israel, March 28, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) (\"PainReform\" or the \"Company\"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced completion of treatment for the first part, of its two-part Phase 3 clinical trial of PRF-110, in which 15 patients were enrolled and administered PRF-110 intra-operatively to review surgeon’s handling of PRF-110, optimize drug product placement, enabling tools and measure peak blood concentration. 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 prior to closure to provide localized and extended post-operative analgesia. The first part of the Phase 3 trial was conducted at two clinical sites in Texas (First Surgical Hospital in Bellaire Texas and Endeavor Clinical Trials in San Antonio Texas). This first part of the study also served to train surgeons in best practices for administering PRF-110, optimally covering inner wound surfaces for most efficient analgesia. Initial pharmacokinetic data on the first 15 patients is expected in May 2023. Following the successful conclusion of this part of the trial the second, larger, part of the trial will start recruiting patients. Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “Completion of enrollment and administration of PRF-110 in the first part of our Phase 3 clinical trial marks a major clinical milestone for PRF-110. Notably, this was the first time PRF-110 was used in bunionectomy procedures and we took this opportunity to refine the procedure for applying PRF-110 during this form of surgery. After we witnessed these surgeries first hand in Houston and in San Antonio, as well as the application of PRF-110, we are highly encouraged by what we have seen so far. We look forward to evaluating the PK results, and then immediately transitioning to the next part of our Phase 3 trial.” The second part of the trial will be double-blinded, in which the Company plans to randomize approximately 400 patients...