PainReform Ltd. (Nasdaq: PRFX), a clinical-stage pharmaceutical company specializing in reformulating existing therapies, has provided an update on its Phase 3 clinical trial for PRF-110. This trial evaluated the drug’s efficacy in managing post-surgical pain for patients undergoing bunionectomies.
While the company previously reported statistically significant pain reduction compared to a placebo during the initial 48 hours post-surgery, the final 24 hours of the 72-hour study period presented data inconsistencies. Despite efforts to clarify these discrepancies, PainReform has concluded that the data from the final 24-hour period does not meet the study’s primary endpoint requirements.
Although the primary endpoint was not met, the company is actively pursuing research and development to better understand PRF-110’s pharmaco-kinetics and pharmaco-dynamics based on the collected data. This research aims to address the identified issues and support future clinical trials. The company is using advanced in-vitro models to investigate the discrepancies observed in the final 24 hours of the 72-hour study period before proceeding with further clinical work. This research is vital to refining the drug’s profile and maximizing its potential effectiveness in future evaluations. Concurrently, PainReform is evaluating its strategic options, though there are no guarantees of specific outcomes or increased shareholder value resulting from this review.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
