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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 ...
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection ~","length":84,"tagName":"p"},{"type":"text","content":"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.","length":417,"tagName":"p"},{"type":"text","content":"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. 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.","length":685,"tagName":"p"},{"type":"text","content":"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.","length":275,"tagName":"p"},{"type":"text","content":""This is a significant milestone for Ensysce and for the millions of patients who depend on opioid analgesia during recovery from serious surgery." said Dr. Lynn Kirkpatrick, CEO of Ensysce. "Initiation of our pivotal Phase 3 program moves us one step closer to redefining pain care. We aim to show that PF614 can reliably deliver the level of pain control patients need, while its built-in protective features help safeguard against the dangers of abuse. We believe PF614 represents a next generation of safety for opioid therapy and this Phase 3 trial marks a significant step on our pathway to commercialization."","length":636,"tagName":"p"},{"type":"text","cont...