Ensysce Biosciences Completes 50% Enrollment for PF614 Clinical Trial

Ensysce Biosciences has enrolled 50% of subjects targeted for interim review in its pivotal Phase 3 clinical trial of PF614, the Company's next-generation opioid candidate engineered to deliver powerful pain relief with built-in abuse protection. Enrollment began in late December 2025 and is progressing rapidly across three U.S. clinical sites: CenExel JBR; CenExel Atlanta; and ERG-HD Research. The study is being led by Dr. Todd Bertoch, Dr. Jessica McCoun, and Dr. D'Aunno, recognized experts in anesthesiology and pain management. The pivotal PF614-301 trial is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of PF614 for the treatment of moderate to severe pain following abdominoplasty. The study is designed to demonstrate PF614's ability to deliver consistent, clinically meaningful post-surgical pain relief using twice-daily dosing. PF614 leverages Ensysce's proprietary chemical activation technology, which is designed to keep the opioid inactive until swallowed, limiting the impact of tampering and dose manipulation while enabling extended-release pain control. This approach is intended to address one of the central challenges in modern pain care: delivering opioid-level efficacy while reducing the risks of abuse and misuse.