PainReform Ltd. has announced initial topline data from its Phase 3 clinical trial evaluating PRF-110 for post-surgical pain management in patients undergoing bunionectomy. The data indicates that PRF-110, an oil-based, extended-release formulation of ropivacaine, demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery.
Promising Early Results
The initial analysis suggests that PRF-110 has the potential to provide effective pain relief during the critical early postoperative period. Ehud Geller, Chairman and interim CEO of PainReform, expressed cautious encouragement, highlighting PRF-110's promise as an effective solution for post-surgical pain.
Data Incoherence and Ongoing Analysis
However, the data pertaining to the subsequent 24-hour period, which is essential for assessing the primary endpoint of the trial, is currently unclear due to incoherence. PainReform is actively collaborating with Lotus Clinical Research to resolve this issue and complete the analysis of this portion of the data. There is no assurance that the effort to resolve the incoherence will be successful.
About the Phase 3 Trial
The bunionectomy Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study. In the first part, 15 patients were enrolled in an open-label study to measure safety and plasma concentration levels. All safety requirements were met, and the study proceeded to the second part, where 428 patients were randomized into three cohorts: PRF-110, Naropin® (ropivacaine), and placebo in a 2:2:1 ratio. PRF-110 was administered intra-operatively.
The primary efficacy endpoint is the mean area under the curve (AUC) of the numerical rating scale (NRS) of pain intensity scores over 72 hours (AUC0-72) for PRF110 compared with placebo. Secondary efficacy endpoints include mean AUC0-72 of the NRS of pain intensity scores for PRF110 compared with plain ropivacaine, total post-surgery opioid consumption (in morphine equivalents) over 72 hours for PRF110 compared with saline placebo, the proportion of subjects who are opioid-free through 72 hours for PRF110 compared to that of plain ropivacaine, and the total postoperative opioid consumption through 72 hours for PRF110 compared to that of plain ropivacaine. Safety endpoints include the incidence of treatment-emergent adverse events and serious adverse events, physical examination, vital signs, and wound healing.
PRF-110: Extended Pain Relief
PRF-110 is PainReform's proprietary, oil-based, extended-release formulation of ropivacaine, a widely used local anesthetic. It is designed to provide prolonged pain relief while reducing the need for opioids, potentially enhancing patient recovery and safety in the post-surgical setting. If the first Phase 3 clinical trial of patients undergoing bunionectomy is successful, PainReform plans to initiate a second trial for pain treatment of hernia repair operations.
