PainReform Reports Positive Safety Profile for PRF-110
PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company") is a clinical-stage specialty pharmaceutical firm dedicated to reformulating established therapeutics. The Company has announced promising early safety results from its ongoing Phase 3 study of PRF-110, a proprietary formulation aimed at managing post-surgical pain following bunionectomy procedures.
Study Overview
The study has successfully completed enrollment, involving a total of 443 patients across eight clinical sites in the United States. This randomized, double-blind, placebo-controlled trial aims to assess both the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgery. Preliminary safety data indicates a low occurrence of adverse events, averaging only one per participant.
Management Insights
Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, expressed, "We are very encouraged by the early safety data from our Phase 3 bunionectomy study, which underscores the potential of PRF-110 to revolutionize post-surgical pain management. The impressive safety profile of PRF-110, which builds on 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 achievement represents a significant advancement in our mission to provide a safer and more effective therapeutic option for managing post-operative pain."
Evidence Supporting PRF-110
The safety and efficacy of PRF-110 are further backed by comprehensive clinical and preclinical testing, establishing it as a potential frontrunner in the market. The company is dedicated to progressing PRF-110 through the final phases of clinical development, aiming to offer patients and healthcare providers a novel, non-opioid solution for managing post-surgical pain.
About PainReform
PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics. The Company’s lead product, PRF-110, is based on the local anesthetic ropivacaine and targets the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is administered directly into the surgical wound bed before closure, providing localized and prolonged postoperative analgesia. The Company’s proprietary extended-release drug-delivery system is designed to manage post-surgical pain effectively without requiring repeated doses or increasing the risk of opioid use.
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 formulation designed for post-surgical pain management, utilizing the local anesthetic ropivacaine.
What were the primary results of the Phase 3 study?
The Phase 3 study demonstrated a low rate of adverse events, averaging just one per subject, which indicates a favorable safety profile.
Where was the clinical trial conducted?
The clinical trial took place at eight sites across the United States, enrolling a total of 443 patients.
How does PRF-110 differ from traditional pain relief methods?
PRF-110 is designed to provide localized and extended postoperative pain relief without the need for repeated doses or reliance on opioids.
What are the future plans for PRF-110?
The company is focused on advancing PRF-110 through the final stages of clinical development to introduce this non-opioid solution to the market.
