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PainReform Announces Commencement of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery
Initial pharmacokinetic data on first 15 patients expected in May 2023 TEL AVIV, Israel, March 14, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX)
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Initial pharmacokinetic data on first 15 patients expected in May 2023\nTEL AVIV, Israel, March 14, 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 that it has commenced a Phase 3 clinical trial of PRF-110, the Company’s lead drug candidate, targeting the post-operative extended pain relief market. 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 study will be conducted in two parts. In the first part, a total of 15 patients will be enrolled in an open-label safety pharmacokinetic (PK) study at two clinical sites in Texas (First Surgical Hospital in Bellaire Texas and Endeavor Clinical Trials in San Antonio Texas). PRF-110 will be administered intra-operatively to measure peak blood concentration in order to further validate safety of the lead formulation. This study will also serve to train surgeons in best practices for administering PRF-110, optimally covering inner wound surfaces for most efficient analgesia. Following the confirmation of peak blood levels, the study will proceed to the second, larger, part of the Phase 3 clinical trial. The second part of the trial will be double-blinded, in which the Company plans to randomize approximately 400 patients at up to seven clinical sites in the U.S. PRF-110 will be administered intra-operatively and patients will be divided into three cohorts, PRF-110, ropivacaine, and placebo in a 2:2:1 ratio. The primary efficacy endpoint is mean area under the curve (AUC) of the numerical rating scale (NRS) of pain intensity scores over 72 hours (AUC0-72) for PRF-110 compared with placebo. Secondary efficacy endpoints include: mean AUC0-72 of the NRS of pain intensity scores for PRF-110 compared with plain ropivacaine; total post-surgery opioid consumption (in morphine equivalents) over 72 hours for PRF-110 compared with saline placebo; the proportion of subjects who are ...