Ensysce Biosciences Completes Final Phase of PF614-MPAR-102 Clinical Study

~ ~ The Second Study Fully Enrolled for Breakthrough Therapy-Designated, First-in-Class Opioid Designed to Protect Against Oral Overdose ~ ~

SAN DIEGO, CA / ACCESS Newswire / August 31, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, and advancing next-generation pain and central nervous system therapeutics designed to reduce abuse and overdose risk, today announced completion of enrollment in the final stage of the PF614-MPAR-102 clinical study. The study evaluated its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology.

Unlike traditional abuse-deterrent technologies, PF614-MPAR is engineered to actively protect against oral overdose, addressing one of the most persistent risks in opioid therapy. Its proprietary chemical-control mechanism provides therapeutic opioid exposure when used as prescribed and automatically limits additional release when excessive doses are taken. This built-in "safety switch" establishes a new therapeutic paradigm: opioids designed not only for efficacy, but also for controlled exposure under misuse conditions.

Part 3 of this second PF614-MPAR study, supported by the National Institute on Drug Abuse (NIDA)1, was designed to further characterize the drug's protective profile against a full range of dosing scenarios. Clinical data published to date demonstrates PF614-MPAR maintains consistent therapeutic plasma levels at normal doses while significantly blunting exposure increases at supratherapeutic levels.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, stated, "Completing enrollment in this second PF614-MPAR study marks an important milestone for Ensysce as we advance a Breakthrough Therapy-designated program targeting one of the most urgent challenges in prescription opioid therapy: overdose risk. PF614-MPAR is designed to deliver therapeutic opioid exposure when used as prescribed while limiting additional release at excessive doses, a differentiated approach we believe could redefine prescription opioid safety. With nearly 80,000 people in the U.S. still dying each year from opioid overdose, prescription opioids remain a significant part of this crisis2. By embedding overdose protection directly into the molecule, MPAR® represents a potentially new class of chemically engineered opioids and an important step toward a safer standard of care for pain management."

Beyond pain management, Ensysce is leveraging its TAAP and MPAR® technologies to expand its pipeline across additional high-need therapeutic categories. The Company has identified lead TAAP analogues for amphetamine and methadone, supporting a broader strategy to develop safer treatment options for pain, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder, in addition to its newly acquired psychedelic program for Complex Regional Pain Syndrome.

1Research supporting this program was funded by the National Institute on Drug Abuse of the National Institutes of Health under Award Number DA047682.

2https://drugabusestatistics.org/opioid-epidemic/

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood disorders and address the root cause of chronic pain through central nervous system modulation. The company is also developing a new class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information, please visit www.ensysce.com.

Ensysce Biosciences Company Contact

Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196

Ensysce Biosciences Investor Relations Contact

Shannon Devine MZ North America Main: 203-741-8811 [email protected]

SOURCE: Ensysce Biosciences

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