PainReform Reports Successful Head-to-Head Comparison of PRF-110 Versus Market Leading Post Surgical Analgesia for Extended Postoperative Pain Relief

PRF-110 demonstrated superior formulation properties with respect to surface-tissue spreading

TEL AVIV, Israel, Jan. 03, 2024 (GLOBE NEWSWIRE) --  PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today reported in vitro test results comparing the Company’s lead product, PRF-110, versus the industry leader, as a topical analgesia for postoperative pain relief.

The in vitro tests were designed to mimic the spreadability attribute critically required for post-surgical topical applications. PRF-110 demonstrated superior formulation properties with respect to surface-tissue spreading, including a greater ability to spread evenly due to its viscosity (PRF-110 1,500 cP vs. about 10,000 cP for commercial competitor), and superior surface interaction with surgical tissue based on a slide test, which demonstrated sliding of the formulations down inclined, dry and wet surfaces. In phosphate-buffered saline, the sliding of PRF-110 was twice that of the competitor.

Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are encouraged by these results, which further demonstrate that PRF-110, our long-acting ropivacaine formulation, provides unique and significant benefits for local administration in postoperative pain management. PRF-110 clearly excelled in terms of surface/tissue spreading and staying in place—a key advantage in achieving effective post-surgical pain relief—as it is critical to have even distribution inside the surgical wound. Additionally, PRF-110 is manufactured via a scalable and cost-effective process, is easy to commercialize, and contains excipients that are all FDA-approved as GRAS (generally regarded as safe). As a result, we could not be more encouraged by the outlook for PRF-110 as we advance the current second part of our Phase 3 clinical trial.”

Earlier this year, the Company completed the first part of its Phase 3 clinical trial of PRF-110, in which 15 patients undergoing bunionectomy surgery were enrolled at two clinical sites in Texas. PRF 110 was well tolerated, all adverse events were mild, and no serious adverse events were observed, suggesting a substantial potential advantage to using PRF-110 over opioids. The second part of the trial, currently underway, is a double-blind study, randomizing approximately 400 patients at six clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo.