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PainReform Announces Plans to Commence Second Part of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery Following Positive FDA Review of Drug Master File
Targeting to commence second part of Phase 3 clinical trial in mid-Q4 2023 Trial completion and results expected in mid-2024 TEL AVIV, Israel, Sept. 11, 2023
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Targeting to commence second part of Phase 3 clinical trial in mid-Q4 2023 Trial completion and results expected in mid-2024 TEL AVIV, Israel, Sept. 11, 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 plans to commence the second part of the Company’s phase 3 trial to evaluate PRF-110 in patients undergoing bunionectomy surgery. Starting the second part of the bunionectomy Phase III study follows the clearance by FDA of the DMF (Drug Master File) held by the Company’s API manufacturer. This second part of the trial is expected to proceed in the next quarter of 2023. As announced earlier this year, the company completed the first part of its Phase 3 clinical trial of PRF-110, in which 15 patients undergoing bunionectomy surgery were enrolled at two clinical sites in Texas. The Company reported positive safety data in the first part of the Phase 3 clinical trial with no serious adverse events (SAEs) reported, suggesting a substantial potential advantage to using PRF-110 over opioids. 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). The upcoming 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 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 comprise the remainder of the PRF-110 formulation have been designated by the FDA as Generally Recognized as Safe (GRAS), mitigating many potential safety issues common in drug development. Key surgical benefits observed to date include: PRF-110 does not alter the integrity of standard surgical devices, such as sutures and meshes used in a large variety of surgical proceduresPRF-110 does not interfere with normal macro and microscopic wound healing of surgical incisions in soft tissue and bone modelsPRF-110 does not alter the tensile strength of healed skin at the surgical sites in an a...