PainReform Phase 3 trial on PRF-110 did not meet primary endpoint

PainReform (PRFX) announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy. PainReform previously disclosed initial topline data from its Phase 3 clinical trial in which it reported that it demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. Yet, at that time, data pertaining to the last 24-hour period of the 72-hour study follow-up was unclear, and efforts were made to resolve the incoherence and complete the analysis. Following further investigation, PainReform has determined that the data from the final 24-hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement, and therefore, it did not meet the primary endpoint of the study.