PainReform Announces Positive Pharmacokinetic (PK) Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
Reports excellent compliance with FDA safety requirements in the first part of its Phase III with 15 patients
TEL AVIV, Israel, May 18, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive pharmacokinetic (PK) data in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas.
During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax). Cmax value among all of the 15 patients, was approximately 10% of the safety window set by FDA.
Ilan Hadar, Chief Executive Officer of PainReform, stated, "We are encouraged by the PK results which demonstrated that PRF-110 showed a favorable pharmacokinetic profile, a critical step towards regulatory approval. The successful completion of the safety and PK determination allows us to proceed directly into the second part of our Phase 3 trial.”
The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia.
The forthcoming second part of the trial will be a double-blind study, in which the Company plans to randomize approximately 400 patients at seven clinical sites in the U.S. PRF-110 will be administered intra-operatively, using the experience gained in the study’s first part, and will be divided into three cohorts, PRF-110, ropivacaine, and placebo. As previously reported, PRF-110 provided pain reduction for up to 72 hours post-operatively in the Company’s prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair). PRF-110 is a highly uniform solution, resulting in consistent sustained and extended release of the analgesic. Ropivacaine, the active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic. The other components that make up the remainder of the PRF-110 formulation have been designated by the FDA as Generally Recognized as Safe (GRAS), by the FDA, mitigating many potential safety issues.
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 www.painreform.com.
