PainReform, a clinical-stage specialty pharmaceutical company, is set to commence the second part of its phase 3 trial for evaluating PRF-110 in patients undergoing bunionectomy surgery. This significant milestone comes after the U.S. Food and Drug Administration cleared the Drug Master File held by PainReform’s API manufacturer. The second part of the trial is slated to commence in the next quarter of 2023.
Positive Results from Previous Phase 3 Clinical Trial
Earlier this year, PainReform successfully completed the first part of its Phase 3 clinical trial for PRF-110. This initial study involved 15 patients who underwent bunionectomy surgery at two clinical sites in Texas. Promisingly, the company reported positive safety data, highlighting no serious adverse events during the trial. These findings suggest that PRF-110, which PainReform is developing, may offer significant advantages over traditional opioid-based pain management methods.
The Double-Blind Study: Next Steps
Moving forward, PainReform intends to conduct a double-blind study as part of the upcoming second phase of the trial. This study will involve the randomization of 400 patients across seven clinical sites in the United States. By employing this rigorous methodology, PainReform aims to further explore and validate the potential benefits of PRF-110 in managing post-operative pain associated with bunionectomy surgeries.
