PainReform is a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics. Our proprietary extended release drug-delivery system has the potential to prolong the in vivo activity of APIs (active pharmaceutical ingredients), thus increasing the therapeutic window for patient treatment. Our strategy is to incorporate generic drugs with our proprietary extended release drug-delivery system in order to create extended release drug products and to take advantage of the 505(b)(2) regulatory pathway created by the U.S. Food and Drug Administration (“FDA”).
The 505(b)(2) new drug application (“NDA”) process, provides for FDA approval of a new drug based in part on data that was developed by others, including published literature references and data previously reviewed by the FDA in its approval of a separate application.
PRF-110, our first product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized post-operative analgesia.
Market and Competition
We believe that there is a great unmet need for effective, long-lasting, non-opiate treatments for post-operative pain. The current market in post-operative pain treatment is approximately $12 billion, which is expected to grow to over $45 billion by the end of 2026. These market projections are based on the current generation of post-operative pain products, which largely consist of systemically administered opiates. At present, most of the available analgesics are dosed every four to six hours, requiring nursing attention when in the hospital, or discharge of the patients with an excess of drugs to treat anticipated pain. This exposure to opiates is a significant risk factor leading to opiate abuse disorder. PRF-110 was created to prolong analgesia at the surgical site, thus facilitating early post-operative ambulation, recovery and reducing time in hospital.
As reported by the Center for Disease Control and Prevention (“CDC”) in 2017, there are more than 48 million surgical procedures performed annually in the U.S. in both hospitals and in ambulatory surgery centers. We believe that many of these invasive and painful procedures should be eligible for treatment with extended release ropivacaine through our product, PRF-110. The extended release nature of PRF-110 has the potential to reduce pain for up to 72 hours from the time of surgery, thereby obviating the need for additional pain medications. The only currently available extended release product (Exparel) was used in slightly more than 1 million surgeries in 2019. We believe that its comparatively high price of approximately $300 per dose has hampered widespread acceptance to date.
Product and Development Plan
PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure. In a phase 1 safety study conducted in Israel, healthy volunteers were treated with PRF-110. No safety issues were raised, and PRF-110 showed a superior performance when administered to non-operated sites when compared to either a placebo or ropivacaine alone.
In a small 15 patient Phase 2 proof-of-concept clinical study in hernia repair, PRF-110 provided pain reduction for up to 72 hours post-operatively. The surgeons that participated in the PRF-110 Phase 2 trial reported that it was easily integrated into the procedure and was non-disruptive of existing surgical techniques. Ropivacaine, the active drug used in PRF-110, is a safe and well characterized local anesthetic and the other components that make up the remainder of the PRF-110 formulation are classified as GRAS (Generally Regarded As Safe) by the FDA, mitigating many potential safety issues that are common in drug development.
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.
We strive to protect the proprietary technologies that we believe are important to our business, including seeking and maintaining patent protection intended to cover our extended release drug-delivery system. As of December 31, 2019, our exclusively owned patent portfolio includes three U.S. patents, 11 foreign patents and five pending foreign patent applications. The claims of these patents and patent applications are directed toward various aspects of our extended release drug-delivery system and research programs.