Ensysce Biosciences Receives U.S. Patent for Groundbreaking Treatment of Opioid Use Disorder

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) has received a U.S. Patent Notice of Allowance for PF9001, a novel treatment for opioid use disorder (OUD). The patent covers both composition of matter and method of use claims for enzyme-cleavable methadone prodrugs.

The innovative medication utilizes Ensysce's TAAP and MPAR technologies for abuse deterrence and overdose protection. PF9001 represents an advancement over traditional methadone treatment, showing reduced potential for cardiotoxicity and offering overdose protection. The drug demonstrates promise for once-daily dosing with prolonged and predictable effects.

The research, supported by the National Institute on Drug Abuse under Award Number UG3DA050271, aims to address limitations of current OUD treatments, particularly concerns over cardiac side effects, respiratory depression, and overdose risks.

Positive

• Received U.S. Patent Notice of Allowance for PF9001, strengthening intellectual property portfolio
• Demonstrated reduced cardiotoxicity potential compared to traditional methadone
• Potential for improved treatment adherence through once-daily dosing
• Research supported by National Institute on Drug Abuse funding

Negative

• Product still in development phase, not yet FDA approved
• Will face competition from established methadone treatments

Insights

Pharmaceutical Industry Analyst

Ensysce's patent allowance for methadone prodrugs strengthens IP portfolio and validates their abuse-deterrent technology in the valuable OUD market.

Ensysce Biosciences has received a Notice of Allowance from the USPTO for its patent application covering enzyme-cleavable methadone prodrugs, specifically their compound PF9001. This intellectual property protection encompasses both composition of matter and method of use claims, providing comprehensive coverage for their technology.

The patent covers applications of Ensysce's dual technology platforms - TAAP^TM (abuse deterrence) and MPAR^® (overdose protection) - to methadone analogues for treating opioid use disorder (OUD). This represents a strategic expansion of their technology beyond immediate pain management applications.

For context, the OUD treatment market is substantial, with traditional medications like methadone facing limitations due to cardiac side effects, respiratory depression risks, and abuse potential. Ensysce's approach aims to address these specific limitations with their proprietary technology.

The external validation through National Institute on Drug Abuse funding (Award Number UG3DA050271) adds credibility to their scientific approach. For a company with Ensysce's market capitalization ($3.14 million), securing both patent protection and federal research support represents significant progress in building their technology value.

While patent allowance is an important milestone in pharmaceutical development, investors should recognize that significant clinical development work typically remains before commercialization. The company has not disclosed the current development stage of PF9001 or provided a timeline to potential market entry.

Medical Expert

Ensysce's patented methadone prodrug could potentially address critical cardiac and overdose risks in OUD treatment, supported by NIDA funding.

Ensysce's new patent allowance for PF9001 targets a significant unmet need in opioid use disorder treatment. Current methadone therapy, while effective, is by cardiac side effects (QT prolongation), respiratory depression risks, and overdose potential.

The company reports that their data demonstrates reduced cardiotoxicity potential with PF9001 compared to traditional methadone, which would address a major clinical concern. Additionally, they indicate the compound may provide "prolonged and predictable effect following once daily dosing" - an important feature for treatment adherence in the OUD patient population.

From a clinical perspective, the endorsement from Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, adds credibility to the potential safety benefits. The overdose protection mechanism through MPAR^® technology could be particularly valuable given the high-risk profile of OUD patients.

The research received support through the National Institute on Drug Abuse (NIDA), indicating the approach aligns with priorities in addressing the opioid crisis. However, the pathway from patent protection to clinical implementation requires substantial testing to validate preliminary findings on safety and efficacy.

If successfully developed, medications that reduce treatment risks could expand the accessibility of OUD therapy and potentially improve outcomes in this challenging patient population. For clinicians treating OUD patients, advancements in safer medication options would represent a meaningful step forward in addressing both treatment efficacy and risk management.

~ Applies TAAP and MPAR Technology to Produce Novel OUD Treatments ~

~ Prioritizes Safety and Tolerability for OUD Patients ~

SAN DIEGO, CA / ACCESS Newswire / April 23, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for abuse and overdose, today announced it received a Notice of Allowance from the U.S. Patent and Trademark Office for the issuance of a patent entitled: Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof¹ including both composition of matter and method of use claims. PF9001, the innovative medication covered by this patent, is designed to provide a safer treatment option for opioid use disorder (OUD) by using Ensysce's TAAP^TM and MPAR^® abuse deterrent and overdose protection technologies.

Methadone has long been a cornerstone treatment for OUD, but its use has been limited by concerns over cardiac side effects, respiratory depression, and risk of overdose. Ensysce has developed a new class of agents for the treatment for OUD in the form of PF9001. This new drug is a significant advancement in the treatment of OUD, with data demonstrating a reduction in potential for cardiotoxicity, validating MPAR^® overdose protection, and indications of potentially delivering a prolonged and predictable effect following once daily dosing.

Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center who specializes in emergency medicine and toxicology commented, "Novel agents for the treatment of OUD are needed. The MPAR technology applied to methadone analogues has the potential to save lives by reducing overdose."

Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "PF9001 and this approach is the result of years of dedicated research focused on providing safer medications for the treatment of OUD while reducing the risks associated with its therapy. Our novel TAAP and MPAR technology offers patients and providers a safer, more tolerable alternative to current therapy which has been recognized with financial support provided by the National Institute on Drug Abuse. We believe PF9001 could potentially increase treatment adherence and improve outcomes for OUD patients."

¹The research covered by this patent was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA050271.

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-K 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

FAQ

What are the key benefits of Ensysce's (ENSC) new PF9001 treatment for opioid use disorder?

PF9001 shows reduced cardiotoxicity potential, includes MPAR overdose protection, and offers prolonged effects with once-daily dosing, making it potentially safer than traditional methadone treatment.

How does Ensysce Biosciences' TAAP and MPAR technology work in PF9001?

The technologies provide abuse deterrence (TAAP) and overdose protection (MPAR) in PF9001, creating a safer alternative to traditional OUD treatments.

What is the significance of Ensysce's (ENSC) new patent for OUD treatment?

The patent covers enzyme-cleavable methadone prodrugs, including both composition and method of use claims, potentially offering a safer and more tolerable alternative to current OUD therapies.

What federal support has Ensysce's PF9001 development received?

The research was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA050271.