Our first priority is to continue the drive toward commercialization of PRF-110. We plan to begin our pivotal Phase 3 clinical trials as we move toward an NDA approval for PRF-110:
- We have an amassed and extensive toxicology package for PRF-110, demonstrating that there were no PRF-110-related serious adverse events in either healthy subjects or in surgical patients;
- Based on extensive toxicology and pharmacokinetic studies, as well as positive Phase 2 results, the FDA has granted PainReform an IND (Investigational New Drug) for PRF-110 and approved the initiation of Phase 3 clinical trials for the treatment of post-operative pain;
- Unlike many drug trials that take many months to years to complete and which are complex and whose endpoints are difficult to interpret, the planned trials are expected to last for a brief number of days with a 72 hour patient follow up period, with primary endpoints based on measurement of the familiar pain rating scale of 0 (no pain) to 10 (worst imaginable pain);
- Upon completion of the Phase 3 studies, in bunionectomy and hernia repair, if successful, we plan to apply for a New Drug Approval for the management of post-operative pain;
- If and when approved for commercialization, we intend to capitalize on the opportunity and carry out post-approval trials in a number of additional surgical indications including: breast augmentation/reduction, bariatric procedures, hysterectomy, cholecystectomy as well as orthopedic procedures including joint replacements and open fracture repair. We intend to capitalize on these opportunities to become the leader in opiate-free, long-acting local and regional analgesia.
Following the establishment of PRF-110 in the post-operative pain market, we plan to build on our platform technology to broaden our product base. Our extended release drug-delivery system is a non-aqueous, viscous oily formulation that can be used for the delivery of other drugs that are currently difficult to administer for long-term, continuous dosing not requiring an iv access, such as antibiotics and chemotherapeutics. We intend to develop a pipeline of drugs that can be delivered once, using our platform technology, and thereafter be bio-available for extended release. In addition, we plan to expand by developing, acquiring or in-licensing products, or technologies that we believe will be a strategic fit with our focus on the surgical and hospital marketplace.
Once approved, we plan to launch PRF-110 either by ourselves or with a strategic partner that is experienced in marketing products in surgical environments. These environments include:
- Free-standing surgical centers
- Surgical offices