PainReform documents safety information from Phase III bunionectomy trial of PRF-110

Israel-based specialty pharmaceutical company PainReform has announced positive initial safety results from its Phase III bunionectomy trial of PRF-110, a post-surgical pain treatment. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety of PRF-110 in bunionectomy patients. The trial included 443 participants across eight clinical sites in the U.S. Early safety data revealed a low incidence of adverse events, averaging just one per patient. PainReform aims to introduce PRF-110 as a non-opioid option for managing post-surgical pain. The formulation, based on the local anesthetic ropivacaine, is the company's leading product for postoperative pain relief. PRF-110, an oil-based, clear solution, is applied directly to the surgical wound before closure. This drug-delivery system provides prolonged pain relief without the need for repeated doses, potentially reducing opioid usage. The strong safety profile of PRF-110, built on the well-established safety of ropivacaine and GRAS components, positions it as a promising non-opioid alternative in postoperative pain management