PainReform Announces Initial Topline Data for PRF-110 Phase 3 Clinical Trial

Core Insights - PainReform Ltd. has received partial topline data from its Phase 3 clinical trial for PRF-110, which is aimed at managing post-surgical pain in patients undergoing bunionectomy [1][2] - Initial analysis shows PRF-110 has statistically significant superiority over placebo in reducing pain during the first 48 hours post-surgery, indicating its potential effectiveness [2][4] - There are unresolved data issues regarding the subsequent 24-hour period, which is critical for assessing the primary endpoint of the trial [3] Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with PRF-110 being its lead product based on ropivacaine [6] - PRF-110 is designed to provide prolonged pain relief while minimizing the need for opioids, potentially enhancing patient recovery and safety in post-surgical settings [4][6] Clinical Trial Details - The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study involving 428 patients, with PRF-110 administered intra-operatively [5] - The primary efficacy endpoint is the mean area under the curve (AUC) of pain intensity scores over 72 hours, with secondary endpoints including opioid consumption and the proportion of opioid-free subjects [5]