Ensysce Biosciences Announces IRB Approval To Initiate Part 3 Of PF614-MPAR-102 Clinical Study, Marking Final Stage In Study Evaluating MPAR Overdose-Protection Technology.

~ Advances First-in-Class Opioid with Oral Overdose-Protection ~

SAN DIEGO, CA / ACCESS Newswire / April 16, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics engineered to minimize abuse and overdose risk, today announced Investigational Review Board (IRB) approval to initiate Part 3 of the PF614-MPAR-102 clinical study, marking the final stage in this study evaluating its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology.

PF614-MPAR, which received Breakthrough Therapy designation from the U.S. FDA following the PF614-MPAR-101 study, represents a fundamentally new approach to opioid safety. Unlike conventional abuse-deterrent formulations, PF614-MPAR is designed to provide active protection against oral overdose-addressing a critical unresolved risk in opioid therapy. PF614-MPAR uses a proprietary chemical control mechanism that maintains therapeutic opioid exposure under prescribed use, while automatically limiting additional opioid release when excessive doses are ingested. This "built-in safety switch" introduces a new therapeutic paradigm: opioids engineered not only for efficacy, but for controlled exposure under conditions of misuse.