PainReform Ltd. announced a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of post-operative pain. In total, 428 patients have been enrolled at eight clinical sites across the U.S. As the study pain score is being tracked for 72 hours, the end of enrollment is generally the end of the clinical part of the study. The Phase 3 trial, a randomized, double-blind, placebo-controlled study, is designed to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure.

Completion of enrollment in this trial marks a significant milestone in the development of PRF-110 and brings the Company closer to potentially offering a new, non-opioid pain management solution to patients and healthcare providers. This innovative drug candidate leverages a patented, oil-based, extended-release formulation of the well-established local anesthetic, ropivacaine, to provide effective and prolonged pain relief. The Company anticipates reporting top-line results from the Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.

The trial's primary endpoint is to demonstrate a significant reduction in post-operative pain intensity compared to placebo over the first 72 hours after surgery. Secondary endpoints include reduction in post-operative pain intensity compared to Naropin (ropivacaine), evaluating the total consumption of rescue analgesics and the overall safety and tolerability of PRF-110.