ENSC News & Events

Ensysce Biosciences announced the publication of the first clinical manuscript describing its MPAR overdose protection technology. The paper, titled "Formulation and a Phase 1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection," appears online in the Journal of Opioid Management Jan/Feb 2026 issue. PF614-MPAR is the first opioid candidate specifically designed to provide active protection against oral overdose-a limitation not addressed by currently marketed abuse-deterrent formulations. MPAR technology is engineered to maintain therapeutic opioid exposure when taken as prescribed while automatically limiting additional opioid release when excessive numbers of pills are consumed. Data presented in the publication demonstrate that PF614-MPAR achieved appropriate opioid plasma levels under normal dosing conditions, while preventing large increases in opioid delivery when supratherapeutic doses were administered. These findings support the potential for a fundamentally new safety paradigm in opioid analgesia. MPAR previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in January 2024 based on this clinical evidence and the technology is protected by a growing intellectual property portfolio extending through 2042. "This peer-reviewed publication marks a defining milestone not only for Ensysce, but for the field of pain medicine," said Dr. Lynn Kirkpatrick, CEO. "CDC data projects that almost 80,000 people die every year from opioid overdose of which prescription opioids factor into 12.4% of these deaths. These numbers, which amount to 30 deaths per day, are still considered a major health crisis. Importantly, to combat against overdose, MPAR introduces a new class of chemically programmed opioids designed to protect patients even when dosing errors or misuse occur."

Ensysce Biosciences announced its Board of Directors has initiated a formal review of a broad range of strategic alternatives intended to enhance shareholder value and support the continued advancement of the Company's proprietary technologies. Potential strategic alternatives may include, among other things, strategic partnerships, licensing arrangements, capital formation transactions, business combinations, asset sales or other corporate transactions. There can be no assurances that the review will result in any specific transaction, and the Company has not set a timetable for the completion of the review process. "Our technologies were designed to fundamentally improve the safety profile of opioids, and we believe they have relevance well beyond a single class." said Dr. Lynn Kirkpatrick, CEO. "We are thoughtfully exploring strategic alternatives that we believe could unlock additional value for our shareholders while allowing us to remain disciplined in our executionand focused on advancing our TAAP and MPAR platforms."

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.