HERZLIYA, Israel/PRNewswire/ -- PainReform Ltd, developer of a proprietary reformulation technology, has received FDA approval to conduct two pivotal Phase III clinical trials for post-operative pain relief in soft and hard tissue.
"This green light from the FDA enables us to progress towards receiving an NDA (New Drug Approval) for the general use of our breakthrough technology in post-operative extended pain relief," said Dr. Eli Hazum, CEO of PainReform.
The trials will use PRF-110, a proprietary extended release version of ropivacaine (Naropin) which provides long relief of post-surgical incision pain. In a Phase II study, PRF-110 demonstrated pain relief for up to 72 hours – ten times longer than the current standard of care.
PRF-110 has the complete set of attributes, including efficacy, safety, physical properties and low-cost, to position it as the leading candidate to carve out the biggest share of this very large market.
The estimated market potential for pain relief drugs is $5 Billion. A significant need exists to prolong post-operative pain relief. The current medical habit of resorting to opiate-based narcotics is identified by FDA as an epidemic with substantial health complications and addiction of patients – and their resultant costs.
PainReform is currently raising $15 million to conduct the trials.
PRF-110 is an extended release version of ropivacaine providing longer relief of post-surgical incision pain – up to 72 hours.
PRF-110 has undergone extensive preclinical testing of both safety and extended analgesic efficacy, a Phase I study using an experimental pain model in healthy volunteers and a Phase II efficacy study in postsurgical hernia patients. In both studies, PRF-110 demonstrated: extended release of ropivacaine; a low Cmax; and long-acting analgesia activity of up to 72 hours. Results indicate RPF-110 is well-tolerated and does not interfere with wound healing. Importantly, pain control appears to last for up to 10 times longer than the relief which is observed with Naropin™ - the currently used version of ropivacaine.
PainReform has developed a proprietary oily formulation technology enabling prolonged local release of analgesic drugs into wounds and surgical incision sites. The Company's lead product uses this technology to extend the pain relief of ropivacaine. The technology platform can novel formulations of other approved products. PRF has a robust granted patent estate through 2033.
Over 70 million surgical procedures are performed annually in the US, of which 30 million are considered eligible for PRF-110. This represents a market potential of over $5 billion. A significant need exists to prolong the duration of post-surgical pain relief to facilitate patient recovery and reduce hospitalization time without resorting to opiate-based narcotics. The latter often lead to increased hospital stays, complications and have the potential for abuse.