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.
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.
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
· Improves patients' mobility to accelerate recovery and hospital discharge
· Reduces the need for opiates and minimizes side effects
· 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
PainReform Ltd has applied for 2 PCT applications on its platform technology and on its lead product
Development Status and forward looking plans
Proof of concept data in pre-clinical models and clinical studies in healthy volunteers and in hernia patients demonstrates clear advantages of PRF-110 over currently used analgesic agents.