Clinical Trials
Phase II
PainReform sponsored a Phase 2 proof-of-concept study designed to assess the safety and efficacy of PRF-110 in hernia repair surgeries. The study was performed at the Sourasky Medical Center, the Galilee Medical Center and the Assaf Harofeh Medical Center, all located in Israel.
The primary objective of the study was to evaluate the safety and tolerability of PRF 110 following hernia repair surgery performed by abdominal incision.
The secondary objective was to evaluate pain intensity and the use of rescue pain medications following hernia surgery and application of PRF 110 at the incision site. A comparison of the results to placebo historical data evidenced lower average pain scores for up to 72 hours in comparison to the use of ropivacaine alone, which provided pain relief for only 2- to 6 hours.
In this limited study PRF-110 provided pain reduction for up to 72 hours post-operatively.
Prior to undertaking the Phase 2 study PRF-110 was, at the request of the FDA, rigorously tested in preclinical models of wound healing and in which it was shown to have no deleterious effect on time to healing, on the strength of the healed skin, on bones and on the integrity of sutures and surgical mesh.
Phase III
Based on extensive toxicology and pharmacokinetic measures, as well as positive Phase 2 results, the FDA has granted us an IND (Investigational New Drug) for PRF-110 and approved the initiation of Phase 3 trials for the treatment of post-operative pain.
Once PRF-110 is approved for hernia repair and for bunionectomy, we expect that these indications will be the focus of our initial commercialization efforts.
Following approval we intend to quickly capitalize on the opportunity and carry out post-approval Phase 4 clinical trials in a number of additional surgical indications, including breast augmentation/reduction, bariatric procedures, hysterectomy and cholecystectomy, as well as orthopedic procedures including joint replacements and open fracture repair.
