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PainReform Announces Positive Safety Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
Reports Solid Safety Profile of PRF-110 and No Serious Adverse Events among First 15 Patients TEL AVIV, Israel, May 01, 2023 (GLOBE NEWSWIRE) -- PainReform
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Reports Solid Safety Profile of PRF-110 and No Serious Adverse Events among First 15 Patients\nTEL AVIV, Israel, May 01, 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 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. Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “We are pleased to report positive safety data in the first part of our Phase 3 clinical trial, suggesting a substantial potential advantage to using PRF-110 over the local anesthetic, ropivacaine. In addition, the absence of any serious adverse events marks a significant clinical milestone of our non-opioid, pain-relieving treatment for postoperative pain. Importantly, the first part of the trial allowed us to train the physicians how to best practice the administration of PRF-110 in advance of the second part of our trial. “We look forward to presenting the pharmacokinetic (PK) data on the first 15 patients next month and then proceeding to the second stage of the Phase 3 trial. Assuming our Phase 3 trials are successful, we believe PRF-110 has the potential to become standard-of-care within the estimated $12 billion postoperative pain treatment market as...