Ensysce Biosciences Receives U.S. Patent for Groundbreaking Treatment of Opioid Use Disorder
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.
Ensysce Biosciences (NASDAQ:ENSC) ha ricevuto un avviso di concessione di brevetto negli Stati Uniti per PF9001, un nuovo trattamento per il disturbo da uso di oppioidi (OUD). Il brevetto copre sia la composizione chimica sia i metodi d’uso per i pro-farmaci di metadone attivabili da enzimi.
Il farmaco innovativo sfrutta le tecnologie TAAP e MPAR di Ensysce per prevenire l’abuso e proteggere da sovradosaggio. PF9001 rappresenta un progresso rispetto al trattamento tradizionale con metadone, mostrando un potenziale ridotto di cardiotossicità e offrendo protezione contro il sovradosaggio. Il medicinale promette una somministrazione una volta al giorno con effetti prolungati e prevedibili.
La ricerca, sostenuta dal National Institute on Drug Abuse con il premio UG3DA050271, mira a superare i limiti degli attuali trattamenti per l’OUD, in particolare le preoccupazioni legate agli effetti collaterali cardiaci, alla depressione respiratoria e ai rischi di sovradosaggio.
Ensysce Biosciences (NASDAQ:ENSC) ha recibido un aviso de concesión de patente en EE. UU. para PF9001, un tratamiento novedoso para el trastorno por uso de opioides (OUD). La patente cubre tanto la composición química como los métodos de uso de profármacos de metadona activados por enzimas.
El medicamento innovador utiliza las tecnologías TAAP y MPAR de Ensysce para prevenir el abuso y proteger contra sobredosis. PF9001 representa un avance respecto al tratamiento tradicional con metadona, mostrando un menor potencial de cardiotoxicidad y ofreciendo protección contra sobredosis. El fármaco promete una dosificación diaria con efectos prolongados y predecibles.
La investigación, apoyada por el National Institute on Drug Abuse bajo el número de premio UG3DA050271, busca superar las limitaciones de los tratamientos actuales para el OUD, especialmente las preocupaciones sobre efectos secundarios cardíacos, depresión respiratoria y riesgos de sobredosis.
Ensysce Biosciences (NASDAQ:ENSC)는 오피오이드 사용 장애(OUD) 치료를 위한 신약 PF9001에 대해 미국 특허 허가 통지서를 받았습니다. 이 특허는 효소에 의해 분해되는 메타돈 프로드럭의 조성물 및 사용 방법을 포함합니다.
이 혁신적인 약물은 남용 방지 및 과다복용 보호를 위해 Ensysce의 TAAP 및 MPAR 기술을 활용합니다. PF9001은 기존 메타돈 치료법보다 심장 독성 가능성이 낮고 과다복용에 대한 보호 기능을 제공하는 진전을 나타냅니다. 이 약물은 하루 한 번 복용으로 장시간 예측 가능한 효과를 기대할 수 있습니다.
국립 약물 남용 연구소(National Institute on Drug Abuse)의 지원을 받아 진행된 연구(상금 번호 UG3DA050271)는 현재 OUD 치료법의 한계, 특히 심장 부작용, 호흡 억제 및 과다복용 위험 문제를 해결하는 것을 목표로 합니다.
Ensysce Biosciences (NASDAQ:ENSC) a reçu une notification d'acceptation de brevet aux États-Unis pour PF9001, un traitement innovant du trouble lié à l'utilisation d'opioïdes (OUD). Le brevet couvre à la fois la composition et les revendications d'utilisation des prodrogues de méthadone clivables par enzymes.
Ce médicament novateur utilise les technologies TAAP et MPAR d'Ensysce pour dissuader l'abus et protéger contre la surdose. PF9001 représente une avancée par rapport au traitement traditionnel à la méthadone, avec un potentiel réduit de cardiotoxicité et une protection contre la surdose. Ce médicament promet une administration quotidienne avec des effets prolongés et prévisibles.
La recherche, soutenue par le National Institute on Drug Abuse sous le numéro de subvention UG3DA050271, vise à pallier les limites des traitements actuels de l'OUD, notamment les inquiétudes concernant les effets secondaires cardiaques, la dépression respiratoire et les risques de surdose.
Ensysce Biosciences (NASDAQ:ENSC) hat eine US-Patenterteilung für PF9001 erhalten, eine neuartige Behandlung für Opioidgebrauchsstörung (OUD). Das Patent umfasst sowohl die Zusammensetzung als auch die Anwendungsansprüche für enzymspaltbare Methadon-Prodrugs.
Das innovative Medikament nutzt Ensysces TAAP- und MPAR-Technologien zur Missbrauchsverhinderung und Überdosierungsschutz. PF9001 stellt eine Weiterentwicklung gegenüber herkömmlicher Methadonbehandlung dar, mit reduziertem kardiotoxischem Potenzial und Schutz vor Überdosierung. Das Medikament verspricht eine einmal tägliche Dosierung mit langanhaltender und vorhersehbarer Wirkung.
Die Forschung, unterstützt vom National Institute on Drug Abuse unter der Fördernummer UG3DA050271, zielt darauf ab, die Einschränkungen aktueller OUD-Behandlungen zu überwinden, insbesondere Bedenken hinsichtlich kardialer Nebenwirkungen, Atemdepression und Überdosierungsrisiken.
- 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
- Product still in development phase, not yet FDA approved
- Will face competition from established methadone treatments
Insights
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 - TAAPTM (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 (
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.
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 TAAPTM 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 (TAAPTM) 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
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