Ensysce Biosciences initiates enrollment in Phase 3 trial of PF614

Ensysce Biosciences (ENSC) announced that the first patient has been enrolled in the Company’s pivotal Phase 3 clinical trial of PF614, its lead product candidate. This study, PF614-301, ‘A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty’,” is designed to demonstrate PF614’s ability to provide strong, consistent post-surgical pain relief while incorporating an innovative chemical mechanism intended to reduce the risk of abuse. The trial will also evaluate PF614’s potential to provide a smoother, safer treatment of severe acute pain using twice daily dosing with reduced highs and lows in blood drug concentration, an approach which is seen as beneficial by leaders in the field. Enrollment has commenced at CenExel JBR in Salt Lake City, Utah, under the leadership of Dr. Todd Bertoch, and CenExcel Atlanta under the leadership of Dr. Jessica McCoun, both recognized expert in anesthesiology and pain medicine and the study’s Principal Investigators.