PainReform Announces Favorable Safety Profile of PRF-110, Indicating Potential for Use in New Surgical Applications Requiring Higher Doses

TEL AVIV, Israel, Aug. 07, 2024 (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 compelling safety data for its lead product candidate, PRF-110. This data, derived from pharmacokinetic (PK) studies in both herniorrhaphy and bunionectomy clinical trials, highlights PRF-110's promising safety profile, with maximum blood levels (Cmax) recorded at approximately 10% of the FDA-established safety threshold.

Local anesthetics, such as ropivacaine—the active pharmaceutical ingredient (API) in PRF-110—and bupivacaine, the API in other products like Exparel and Zynrelef, are known for their correlation between Cmax levels and the risk of cardiovascular toxicity and central nervous system (CNS) adverse events. The threshold for these adverse events is typically between 2000-4000 ng/ml (Clinical Drug Investigation, 2013, 33 pp. 109-115). The results from the PRF-110 studies suggest that the product remains well within safe limits, underscoring its potential for broader surgical applications.

PRF-110 is a viscous, oil-based, clear solution designed for direct application into the surgical wound bed before closure, providing localized and extended postoperative analgesia. The formulation ensures controlled release of the API over time, avoiding dose dumping. The use of ropivacaine in PRF-110, regarded as the safest long-acting local anesthetic (Local and Regional Anesthesia, 2010; 3: 11–19), is a significant advantage, offering the potential for higher doses and larger product volumes in various surgical operations compared to other anesthetics.

"The safety data we've observed with PRF-110 is highly encouraging and supports our belief in its potential to enhance patient care in surgical settings," said Ehud Geller, Chairman and interim Chief Executive Officer of PainReform. "With its favorable safety profile and the ability to use higher doses, PRF-110 has the potential to address significant unmet needs in postoperative pain management, well beyond just herniorrhaphy and bunionectomy, thereby reducing reliance on opioids and improving overall patient outcomes across a wide range of surgical procedures."

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.

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Contact: 

Crescendo Communications, LLC

Tel: 212-671-1021

Email: [email protected]

Dr. Ehud Geller

Chairman and interim Chief Executive Officer

PainReform Ltd.

Tel: +972-54-4236711

Email: [email protected]