EXCLUSIVE: PainReform Reaches 50% Enrollment Target For Phase 3 Study For Its Lead Postoperative Pain Drug

On Tuesday, PainReform Ltd PRFX announced it reached the 50% enrollment target for the second part of the Phase 3 clinical trial of PRF-110 in bunionectomy. 

A bunion is a bony bump that forms at the base of the big toe, forming a union with a foot bone called the first metatarsal. The bunion is a foot deformity comprising bone and soft tissue.

Bunion removal is a surgical procedure that corrects a deformed area of the foot near the big toe. Bunion removal is sometimes called a bunionectomy, bunion surgery, or hallux valgus correction.

Over 200 patients have been enrolled, of up to approximately 400 at eight clinical sites across the U.S.

Ilan Hadar, Chief Executive Officer of PainReform, stated, “Importantly, to date there have been no reported serious adverse events, underscoring PRF-110’s potential safety gathered until today. We’re on track to wrap up enrollment on schedule and are looking forward to sharing the early results in Q3 2024. We remain highly encouraged by the potential of PRF-110 to redefine the standard of care in the multibillion-dollar postoperative pain management market, as well as offering patients a compelling alternative to systemic opioids, which have contributed to the global opioid epidemic.”

PRF-110, the company’s lead product, is based on the local anesthetic ropivacaine, which targets the postoperative pain relief market. 

PRF-110 is an oil-based, viscous, clear solution deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia. 

The company’s proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. 

Price Action: PRFX shares closed at $1.77 on Monday.