Ensysce secures IRB approval of final phase of PF614-MPAR-102 study

Ensysce Biosciences (ENSC) announced Investigational Review Board approval to initiate Part 3 of the PF614-MPAR-102 clinical study, marking the final stage in this study evaluating its novel MPAR 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. Previously published clinical data demonstrate that PF614-MPAR delivers consistent, therapeutic plasma levels under normal dosing conditions, while significantly attenuating increases in opioid exposure at supratherapeutic doses. Part 3 of the PF614-MPAR-102 study is designed to further characterize this protective effect across a range of dosing scenarios.