PainReform Provides Further Update on Phase 3 Clinical Trial of PRF-110

Core Viewpoint - PainReform Ltd. announced that its Phase 3 clinical trial for PRF-110 in post-surgical pain management did not meet the primary endpoint due to unclear data from the final 24-hour period, but the company is initiating R&D activities to refine the drug's pharmacokinetics and pharmacodynamics [2][6][7] Group 1: Clinical Trial Update - The Phase 3 clinical trial initially reported statistically significant superiority of PRF-110 over placebo in reducing pain during the first 48 hours post-surgery [6] - The final 24-hour data was unclear, preventing the study from meeting its primary endpoint of a 72-hour follow-up [2][6] - The company is focused on resolving the data issues through high-level in-vitro models before proceeding with additional clinical work [7] Group 2: Product Information - PRF-110 is based on the local anesthetic ropivacaine and is designed for postoperative pain relief [7] - The product features an oil-based, viscous solution that is applied directly into the surgical wound to provide localized and extended analgesia [7] - The proprietary extended-release drug-delivery system aims to reduce the need for repeated doses and minimize opioid use [7] Group 3: Future Directions - The company is committed to leveraging learnings from the trial to enhance PRF-110's profile for future evaluations [7] - Ongoing R&D efforts are aimed at deepening the understanding of PRF-110's pharmacological properties [7] - PainReform is also reviewing its strategic options, although there is no assurance that this will lead to enhanced shareholder value [7]