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1 month ago
Ensysce Biosciences Achieves Major Milestone with Initiation of Enrollment in Pivotal Phase 3 Trial of PF614, Its Next-Generation Opioid
~ Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection ~ SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical trial of PF614, its lead product candidate. This landmark 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.