PainReform

Products

PRF-110

Overview

With over 70 million surgical procedures performed in the U.S alone, a large number of patients require pain relief agents to control post-operational pain. Over 75% of patients  experience moderate-to-extreme pain after surgery necesitating the extensive use of opioids and NSAIDs which have many side effects, demonstrating the significant unmet need for new therapies for the management of post-surgical pain.

 

Lead Product:

PRF-110 provides a prolonged action of the local analgesic agent ropivacaine, a generic local analgesic drug. PRF 110 uses a proprietary technology to allow sustained release of the active material, with the goal of better post-operative pain management while reducing or eliminating the use of opioids and NSAIDs.

PRF-110 is a viscous solution delivered through a sterile, prefilled syringe into the surgical wound. PRF-110 provides prolonged pain relief which is sustained for at least 6 times longer than the immediate release form of ropivacaine (Naropin). PRF-110 is designed to replace existing post-surgical pain products, reduce hospitalization time, costs and recovery time while increasing patient satisfaction. 

Safety Profile

PRF-110 has been shown in both pre-clinical and in a Phase I clinical study to have a safety profile as good as the currently available injectable ropivacaine solution. The formulation utilizes no new chemical entities and employs naturally occurring excipients that are generally regarded as safe (GRAS).

 

Benefits of PRF-110

·         Enhances the duration of action of Ropivacaine for postsurgical pain

·         Facilitates retention of analgesic agent in the wound site

·         Reduces the need for opiates and minimizes side effects

          Improves patients' mobility to accelerate recovery and hospital discharge

·         Convenient administration, a single application, in a sterile, prefilled syringe

·         A simple, one step production process, leads to low COGS enabling commercial      penetration in out of US markets

 

Intellectual Property

PainReform Ltd has two patents, approved in the USA and in Russia, on its platform technology and on its lead product

Development Status and forward looking plans

PRF’s long acting ropivacaine is suitable for local administration for post-operative pain management. PRF-110 is manufactured via a cost effectively process, easily transferable to commercial scale and contains excipients that are all FDA approved GRAS (generally regarded as safe). PRF-110 has shown excellent performance and attributes which are superior to Exparel’s published information on administration, cost of goods, manufacturing efficiency and handling.

Following extensive preclinical testing of both safety and extended analgesic efficacy, PainReform entered human clinical studies.  In a Phase I study in healthy volunteers, PRF-110 demonstrated: extended release of ropivacaine, a low Cmax and long acting analgesia activity.  PRF-110 has then been evaluated in a Phase II efficacy study in 15 postsurgical hernia patients. Results are that RPF-110 is well-tolerated and does not interfere with wound healing as well as exhibits very low Cmax values thus avoiding any CV or CNS adverse events.  Importantly, pain control appears to last for up to 6X longer than the relief reported for Naropin - the current standard of care – and there is a strong indication of no ‘rescue to opiates’.

FDA confirmed 505b2 development plan for PRF 110 and gave a green light to commence two pivotal phase III trials (in soft and hard tissue) towards NDA submission