Established in 2007, PainReform is a venture capital backed, specialty pharmaceutical company with headquarters in Herzeliya. PainReform primarily focuses on developing reformulation of established pain therapeutics PainReform applies it propriety formulation technologies to prolong and enhance efficacy, reduce adverse effects shortening recovery time and reduce the need of augmentation with drugs such as opioids and NSAIDS.
Our strategy is to incorporate generic APIs in our proprietary platform based on GRAS excipients. This platform prolongs and enhances the activity of APIs. Thus, we are able to harness the true value of these APIs for treating patients suffering from pain. At PainReform, we leverage the deep expertise of our team in pain drug development to structure creative clinical trials aiming at the shortened and straightforward regulatory 505(b)(2) pathway. This enables us to rapidly advance products through clinical proof of concept, regulatory approval and commercialization.
This abbreviated development process, from proof-of-concept through Phase III studies, accelerates regulatory submission and commercialization, positioning PainReform to become a formidable presence in the pain medicine arena.
Market & Competition
Post-operative pain (POP) treatment is a growing market ($6B annually) with clear need for better therapeutics. PainReform has developed a proprietary oily formulation that enables prolonged local release of analgesic drugs directly. The Company’s lead product, PRF-110, is an extended release version of ropivacaine (the active ingredient of Naropin) which provides long relief of post-surgical incision pain – up to 48hrs. The technology is a platform that can be used to develop additional novel formulations of other products.
Over 70 million surgical procedures are performed annually in the US. Current post-surgical pain treatment options provide relief typically for only four to six hours. A significant need exists to prolong the duration of post-surgical pain relief as it facilitates patient recovery and reduces hospitalization time and costs, all without resorting to opiate-based narcotics. The only marketed product is a long acting liposomal generic local anesthetic, bupivacaine (Exparel by Pacira, NASDAQ, PCRX), is growing rapidly with >$300M revenues, at peak expected over $1.6B. It serves to validate the market opportunity for PRF-110 and as a financial comparable to the value that can be created with PRF-110.
Product & Development Plan
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 505(b)(2) development plan a gave a green light to commence two phase III trials (soft tissue and hard tissue) of about 350 patients each needed for NDA submission. The Company is currently seeking to raise $25M for conducting the two phase III studies required for PRF-110 approval.