~ ~ Advances First-in-Class, Breakthrough Therapy-Designated Opioid Engineered to Protect Against Oral Overdose ~ ~
SAN DIEGO, CA / ACCESS Newswire / June 26, 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 initiation of the final stage of the PF614-MPAR-102 clinical study. The study is evaluating its novel MPAR (Multi-Pill Abuse Resistance) overdose-protection technology.
Rather than relying on traditional abuse-deterrent technologies, PF614-MPAR is engineered to provide active protection against oral overdose, addressing one of the most persistent risks in opioid therapy. Its proprietary chemical-control mechanism delivers therapeutic opioid exposure during prescribed use while automatically restricting additional release when excessive doses are taken. This built-in "safety switch" establishes a new therapeutic paradigm: opioids designed not only for efficacy, but for controlled exposure under misuse conditions.
Clinical data published to date show that PF614-MPAR maintains consistent, therapeutic plasma levels at normal doses while significantly blunting increases in exposure at supratherapeutic levels. Part 3 of the PF614-MPAR-102 study is intended to further define this protective profile across a broader range of dosing scenarios and is being supported by the National Institute on Drug Abuse (NIDA)1.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce stated, "PF614-MPAR, which received Breakthrough Therapy designation from the U.S. FDA following the PF614-MPAR-101 study, represents what we believe is a fundamentally new approach to opioid safety. Nearly 80,000 people in the U.S. die each year from opioid overdose, with prescription opioids continuing to play a significant role in this crisis2. MPAR represents a new class of chemically engineered opioids designed to actively protect patients, even in situations involving dosing mistakes or misuse. By embedding safety directly into the molecule, MPAR marks an important step toward establishing a new standard for opioid safety."
Beyond pain management, Ensysce is seeking to extend the uses of MPAR across additional therapeutic categories including amphetamines and methadone, with the objective of delivering safer treatments for pain, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder.
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 company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; continuation of government funding; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, available free of charge at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
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
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/ensysce-biosciences-enrolls-first-patient-in-final-phase-of-pf614-mpa-1182785
