PainReform Ltd (Nasdaq: PRFX) has announced positive results confirming the compatibility of its lead product, PRF-110, with surgical sutures in human clinical trials. PRF-110, a non-opiate solution designed for extended post-surgical pain relief, demonstrated no adverse effects on the mechanical properties of commonly used sutures.
The company conducted in vitro studies to evaluate the impact of PRF-110 on both non-absorbable and resorbable sutures. Given the proximity of suture materials to the PRF-110 solution following surgery, it was crucial to determine whether PRF-110 would affect the sutures' mechanical integrity.
Study Design and Results
The mechanical integrity, including breaking force and elongation, of PROLENE™ non-absorbable sutures and Vicryl™ resorbable sutures was tested at baseline and after 14 days of exposure to PRF-110. Comparisons were made to a control group to assess any changes in suture performance.
The results indicated that PRF-110 did not significantly impact the mechanical properties of either PROLENE™ or Vicryl™ sutures. This suggests that the use of PRF-110 in wound closure procedures adjacent to surgical sutures is compatible with suture performance under surgical conditions. These findings align with Phase III clinical results from a bunionectomy trial.
Implications for Post-Surgical Pain Management
"We are pleased to report that PRF-110 has demonstrated compatibility with common surgical sutures in our clinical trials," said Ehud Geller, Chairman and interim CEO of PainReform. "This important milestone underscores the safety and efficacy of PRF-110 as we continue to advance our lead product toward commercialization. The ability to deliver extended pain relief without compromising suture integrity represents a significant advancement in post-surgical care."
PRF-110 is based on the local anesthetic ropivacaine and is designed to provide localized and extended postoperative analgesia. The oil-based, viscous, clear solution is deposited directly into the surgical wound bed prior to closure. PainReform's proprietary extended-release drug-delivery system aims to provide prolonged pain relief, reducing the need for repeated administration and potentially decreasing reliance on opiates.
