PainReform's PRF-110 Shows Positive Safety in Study
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PainReform Announces Positive Safety Profile for PRF-110
PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, announced encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company’s proprietary post-surgical pain formulation.
Details of the Study
The study has now completed full enrollment with a total of 443 patients across eight clinical sites in the United States. It 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 revealed a low incidence of adverse events, averaging just one per subject.
Statements from Management
Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, stated, "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 Generally Recognized As Safe (GRAS) 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 post-operative pain market with a safer and more effective therapeutic option."
Supporting Evidence
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 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, providing localized and extended postoperative analgesia. The Company’s proprietary extended-release drug-delivery system is designed to alleviate post-surgical pain without the need for repeated dose administration while reducing the potential need for opiates.
Contact Information
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
Frequently Asked Questions
What is PRF-110?
PRF-110 is PainReform's proprietary post-surgical pain formulation based on the local anesthetic ropivacaine.
What were the primary results of the Phase 3 study?
The study showed a low incidence of adverse events, averaging just one per subject, indicating a positive safety profile.
Where was the clinical trial conducted?
The trial was conducted across eight clinical sites in the United States with 443 patients enrolled.
How does PRF-110 differ from traditional pain relief methods?
PRF-110 aims to provide localized and extended postoperative analgesia without the need for repeated dose administration or opioids.
What are the future plans for PRF-110?
The company is committed to advancing PRF-110 through the final stages of clinical development to bring this non-opioid solution to market.
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