PainReform's Phase 3 trial of PRF-110 shows positive results for Bunionectomy patients
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- PainReform (NASDAQ:PRFX) reports positive pharmacokinetic (PK) data in Phase 3 trial of PRF-110 for bunionectomy patients.
- Maximum plasma ropivacaine concentrations (Cmax) in the study were approximately 10% of FDA safety limit.
- PRF-110 demonstrated favorable pharmacokinetic profile, paving the way for regulatory approval.
- Phase 3 trial evaluated analgesic efficacy and safety of PRF-110 in unilateral bunionectomy.
- Second part of the trial to include approximately 400 patients at seven U.S. clinical sites.
- PRF-110 provided extended postoperative pain reduction based on prior Phase 2 study.
- PRF-110 formulation comprises well-characterized, safe components recognized by the FDA.
- A bunionectomy is a surgical procedure that moves toes back into the correct position.