Business
PainReform Provides Business Update for the First Quarter of 2023
Reports Progress on Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery TEL AVIV, Israel, May 15, 2023 (GLOBE NEWSWIRE) --
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Reports Progress on Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery\nTEL AVIV, Israel, May 15, 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 provided a business update for the first quarter ended March 31, 2023. Ilan Hadar, Chief Executive Officer of PainReform, stated, “We have made significant progress advancing the Phase 3 clinical trial to evaluate PRF-110, our lead drug candidate, for post-surgical pain relief following bunionectomy surgery. Importantly, we announced the completion of treatment for the first part of Phase 3 clinical trial of PRF-110, in which 15 patients undergoing bunionectomy surgery were enrolled at two clinical sites in Texas. We reported positive safety data in the first part of our Phase 3 clinical trial with no serious adverse events (SAEs) reported, suggesting a substantial potential advantage to using PRF-110 over opioids. According to the U.S. Congress Joint Economic Committee (JEC), the opioid epidemic cost the United States nearly $1.5 trillion in 2020 and is now the main driver of drug overdose deaths.” “We remain on track to complete the analysis of the initial pharmacokinetic data on the first 15 patients later this month and then immediately transition to the larger part of our Phase 3 trial. The upcoming second part of the trial will be a double-blind study, randomizing approximately 400 patients at seven clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo and plain ropivacaine.” “Following the bunionectomy trial, we plan to commence our second Phase 3 trial for post-surgical pain in hernia repair. We believe PRF-110 will significantly extend post-operative analgesia and be significantly safer and less costly to produce than current alternatives. Given the fact that an estimated 99% of current surgeries are treated with opiates and that our proprietary extended-release drug-delivery system has broad potential across a wide range of surgeries, we believe we are well-positioned to become standard of care in the $12 billion post-operative pain relief market.” Financial Results for the First Quarter Ended March 31, 2023 Research and development expenses wer...