PainReform Ltd. has announced initial topline data from its Phase 3 clinical trial evaluating PRF-110 for post-surgical pain management following bunionectomy. The data indicates that PRF-110, an oil-based, extended-release formulation of ropivacaine, achieved statistically significant superiority over placebo in reducing pain during the initial 48 hours after surgery. However, subsequent data from the following 24-hour period, which is critical for assessing the trial's primary endpoint, is currently under review due to data incoherence.
The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study. In the second part of the study, 428 patients were randomized to receive either PRF-110, Naropin (ropivacaine), or placebo in a 2:2:1 ratio. 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 PRF-110 compared to placebo. Secondary endpoints include comparisons between PRF-110 and ropivacaine regarding pain scores, total post-surgery opioid consumption, and the proportion of opioid-free subjects.
Initial Positive Results and Data Challenges
The initial 48-hour data 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 optimism, stating, "We are cautiously encouraged by the statistically significant pain reduction observed in the initial 48 hours, highlighting PRF-110's promise as an effective solution for post-surgical pain."
However, the company is actively working with its contract research organization (CRO), Lotus Clinical Research, to resolve inconsistencies in the data from the subsequent 24-hour period. The resolution of these issues is essential for a complete analysis of the trial's primary endpoint. There is no guarantee that these efforts will be successful.
PRF-110: Extended Pain Relief with Reduced Opioid Use
PRF-110 is PainReform's proprietary formulation of ropivacaine, designed to provide prolonged pain relief and reduce the need for opioids in the post-surgical setting. The drug is administered intra-operatively, directly into the surgical wound bed prior to closure, to provide localized and extended postoperative analgesia.
Trial Design and Endpoints
The bunionectomy Phase 3 trial included an initial open-label study involving 15 patients to assess safety and plasma concentration levels. Following the successful completion of this phase, 428 patients were randomized into three cohorts: PRF-110, ropivacaine, and placebo. The primary efficacy endpoint is the mean AUC of pain intensity scores over 72 hours. Secondary endpoints include opioid consumption and safety assessments, such as adverse events and wound healing.
If this Phase 3 trial is successful, PainReform plans to initiate a second trial for pain treatment in hernia repair operations.
