Ensysce Biosciences Receives EU Patent Expanding its First-in-Class ADHD Therapy with Built-In Abuse and Overdose Protection

~ New ADHD pipeline leverages TAAP™ and MPAR® technologies to improve safety for patients ~

SAN DIEGO, CALIFORNIA / ACCESS Newswire / January 8, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) (“Ensysce” or the “Company”), a clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and overdose, today announced it received a Notice of Allowance from the European Patent Office for the issuance of a patent* for PF8026, a groundbreaking Attention-Deficit/Hyperactivity Disorder (ADHD) therapy. PF8026 is a novel immediate-release amphetamine prodrug protected by the Company’s proprietary TAAP™ (Trypsin Activated Abuse Protection) and MPAR^® (Multi-Pill Abuse Resistance) technologies.

This newly allowed patent, covering both composition of matter and method of use claims, adds to the Ensysce patent portfolio and secures its subject-matter authority in developing safer treatments for ADHD, a condition affecting millions of children and adults worldwide.

Amphetamine stimulants remain the standard of care for ADHD but carry well-documented risks of abuse, dependence, and overdose. Approximately 3.9 million people aged 12 or older misused prescription stimulants in 2023.** PF8026 represents another drug candidate in a new class of ADHD medications that directly address these risks. Unlike traditional formulations, Ensysce’s prodrug design prevents common abuse routes such as nasal inhalation and incorporates MPAR^® overdose protection that has been validated in clinical studies. With PF8026 (immediate release) and PF8001 (extended release) in its ADHD pipeline of TAAP products, Ensysce is expanding its product portfolio to include the first abuse-deterrent, overdose-protected stimulant therapies.

“Applying MPAR^® technology to ADHD medications has the potential to save lives by reducing overdose,” said Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, a leading expert in emergency medicine and toxicology.

“Our mission has always been to deliver safer, more effective therapies in areas of urgent medical need,” said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. “This patent strengthens our ADHD program and underscores the transformative potential of our TAAP™ and MPAR^® platforms, recognized by support from the National Institute on Drug Abuse, and brings us closer to a future where patients with ADHD, pain, or opioid use disorder can be treated effectively without the devastating risks of misuse or overdose.”

* ‘Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof’

**https://www.samhsa.gov/data/sites/default/files/reports/rpt47095/National%20Report/National%20Report/2023-nsduh-annual-national.pdf

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^TM) 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, 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; 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, which are 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 Inc.

View the original press release on ACCESS Newswire