PainReform | MedPath

PainReform's PRF-110 Phase 3 Trial Fails to Meet Primary Endpoint in Post-Surgical Pain Management

5 months ago

• PainReform's Phase 3 clinical trial of PRF-110 for post-surgical pain management in bunionectomy patients did not meet its primary endpoint. • The trial demonstrated statistically significant pain reduction over placebo in the first 48 hours post-surgery, but data from the final 24 hours was unclear. • The company has initiated R&D activities to refine PRF-110's pharmacokinetics and pharmacodynamics based on the study data. • PainReform is reviewing strategic options, including using in-vitro models to address the 72-hour requirement issue before further clinical work.

PainReform's PRF-110 Shows Early Post-Surgical Pain Reduction in Phase 3 Trial

6 months ago

• PainReform's PRF-110 demonstrated statistically significant superiority over placebo in reducing pain within the first 48 hours post-bunionectomy, according to initial Phase 3 data. • The extended-release formulation of ropivacaine aims to provide prolonged pain relief and reduce the need for opioids in post-surgical settings, enhancing patient recovery. • Data for the subsequent 24-hour period is currently under review due to incoherence, with PainReform collaborating with Lotus Clinical Research to resolve the issue. • The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study evaluating PRF-110's analgesic efficacy and safety following bunionectomy.

PainReform's PRF-110 Shows Promise in Phase 3 Bunionectomy Trial, Data Incoherence Hinders Full Analysis

6 months ago

• PainReform's PRF-110 demonstrated statistically significant pain reduction compared to placebo in the first 48 hours post-bunionectomy, suggesting effective early postoperative pain relief. • Data from the subsequent 24-hour period, crucial for the trial's primary endpoint, is currently under review due to inconsistencies, impacting the comprehensive efficacy assessment. • PRF-110, an extended-release formulation of ropivacaine, aims to provide prolonged analgesia and reduce opioid use in post-surgical pain management. • The Phase 3 trial is ongoing, with PainReform collaborating with its CRO to resolve data issues and provide further updates on PRF-110's overall efficacy.

PainReform's PRF-110 Shows Compatibility with Surgical Sutures in Clinical Trials

8 months ago

• PainReform's PRF-110, a non-opioid post-surgical pain relief solution, demonstrates compatibility with both non-absorbable and resorbable sutures in human clinical trials. • In vitro studies showed PRF-110 did not impact the mechanical properties of PROLENE™ and Vicryl™ sutures after 14 days, compared to controls. • These findings support the safety and efficacy of PRF-110 for extended post-surgical pain relief without compromising suture integrity. • PRF-110 is an oil-based, viscous solution of ropivacaine designed for direct application into the surgical wound bed.