PainReform Announces Positive Safety Profile for PRF-110 in Phase 3 Bunionectomy Study
TEL AVIV, Israel, Aug. 20, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company’s proprietary post-surgical pain formulation.
The study, which has now completed full enrollment with a total of 443 patients across eight clinical sites in the United States, is designed as a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure. Initial safety data from the study revealed a low incidence of adverse events, averaging just one per subject.
Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, commented, “We are highly encouraged by the early safety data from our Phase 3 bunionectomy study, which reinforces the potential of PRF-110 to be a game-changer in post-surgical pain management. The outstanding safety profile of PRF-110, which leverages the well-established safety of ropivacaine and GRAS (Generally Recognized As Safe) formulation components, positions it as a promising non-opioid alternative in the post-operative pain market. This milestone marks a significant step forward in our mission to address the $12 billion post-operative pain market with a safer and more effective therapeutic option.”
PRF-110’s safety and efficacy are further supported by extensive clinical and preclinical testing, positioning it as a potential leader in the market. The company remains committed to advancing PRF-110 through the final stages of clinical development, with the aim of providing patients and healthcare providers with a novel, non-opioid solution for post-surgical pain management.
About PainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. The Company's proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit .
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Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email:
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel:
Email:
