Ensysce Biosciences Advances Breakthrough Opioid With Built-In Overdose Protection Following Positive FDA Feedback
Ensysce Biosciences (NASDAQ:ENSC) reported positive feedback from the FDA regarding PF614-MPAR, their breakthrough opioid analgesic with built-in overdose protection. The July 23, 2025 FDA meeting focused on achieving overdose protection labeling and confirmed eligibility for a streamlined 505(b)(2) regulatory pathway.
PF614-MPAR, which has received FDA's Breakthrough Therapy designation, utilizes Ensysce's proprietary TAAP鈩� and MPAR庐 technologies to maintain pain relief while automatically activating overdose protection if prescribed doses are exceeded. The development is supported by NIDA grants through May 2027.
Ensysce Biosciences (NASDAQ:ENSC) ha ricevuto un riscontro positivo dalla FDA riguardo PF614-MPAR, il loro innovativo analgesico oppioide con protezione integrata contro il sovradosaggio. L'incontro con la FDA del 23 luglio 2025 si 猫 concentrato sull'ottenimento dell'etichettatura per la protezione dal sovradosaggio e ha confermato l'idoneit脿 per un percorso regolatorio semplificato 505(b)(2).
PF614-MPAR, che ha ottenuto la designazione Breakthrough Therapy dalla FDA, sfrutta le tecnologie proprietarie TAAP鈩� e MPAR庐 di Ensysce per mantenere l'efficacia analgesica attivando automaticamente la protezione contro il sovradosaggio in caso di superamento delle dosi prescritte. Lo sviluppo 猫 supportato da finanziamenti NIDA fino a maggio 2027.
Ensysce Biosciences (NASDAQ:ENSC) recibi贸 comentarios positivos de la FDA sobre PF614-MPAR, su innovador analg茅sico opioide con protecci贸n integrada contra sobredosis. La reuni贸n con la FDA del 23 de julio de 2025 se centr贸 en obtener la etiqueta de protecci贸n contra sobredosis y confirm贸 la elegibilidad para una v铆a regulatoria simplificada 505(b)(2).
PF614-MPAR, que ha recibido la designaci贸n de Terapia Innovadora de la FDA, utiliza las tecnolog铆as propietarias TAAP鈩� y MPAR庐 de Ensysce para mantener el alivio del dolor activando autom谩ticamente la protecci贸n contra sobredosis si se exceden las dosis prescritas. El desarrollo cuenta con el apoyo de subvenciones NIDA hasta mayo de 2027.
Ensysce Biosciences (NASDAQ:ENSC)電� 雮挫灔霅� 瓿茧嫟氤奠毄 氤错樃 旮半姤鞚� 臧栰稑 須嶊赴鞝侅澑 鞓ろ敿鞓れ澊霌� 歆勴喌鞝� PF614-MPAR鞐� 雽�頃� FDA搿滊秬韯� 旮嶌爼鞝侅澑 頂茧摐氚膘潉 氚涭晿鞀惦媹雼�. 2025雲� 7鞗� 23鞚� FDA 須岇潣電� 瓿茧嫟氤奠毄 氤错樃 霛茧波 須嶋摑鞐� 欷戩爯鞚� 霊愳棃鞙茧┌, 臧勳唽頇旊悳 505(b)(2) 攴滌牅 瓴诫 鞛愱博鞚� 頇曥澑頄堨姷雼堧嫟.
贵顿础鞚� 順侅嫚 旃橂鞝� 歆�鞝�(Breakthrough Therapy designation)鞚� 氚涭潃 PF614-MPAR電� Ensysce鞚� 霃呾瀽鞝� 旮办垹鞚� TAAP鈩� 氚� MPAR庐鞚� 頇滌毄頃橃棳 歆勴喌 須臣毳� 鞙犾頃橂┐靹� 觳橂癌 鞖╇焿 齑堦臣 鞁� 鞛愲彊鞙茧 瓿茧嫟氤奠毄 氤错樃 旮半姤鞚� 頇滌劚頇旐暕雼堧嫟. 鞚� 臧滊皽鞚� 2027雲� 5鞗旉箤歆� NIDA 氤挫“旮�鞚� 歆�鞗愳潉 氚涥碃 鞛堨姷雼堧嫟.
Ensysce Biosciences (NASDAQ:ENSC) a re莽u un retour positif de la FDA concernant PF614-MPAR, leur analg茅sique opio茂de r茅volutionnaire avec protection int茅gr茅e contre le surdosage. La r茅union de la FDA du 23 juillet 2025 s'est concentr茅e sur l'obtention d'un 茅tiquetage de protection contre le surdosage et a confirm茅 l'茅ligibilit茅 脿 une voie r茅glementaire simplifi茅e 505(b)(2).
PF614-MPAR, qui a obtenu la d茅signation de th茅rapie r茅volutionnaire de la FDA, utilise les technologies propri茅taires TAAP鈩� et MPAR庐 d'Ensysce pour maintenir le soulagement de la douleur tout en activant automatiquement la protection contre le surdosage si les doses prescrites sont d茅pass茅es. Le d茅veloppement est soutenu par des subventions NIDA jusqu'en mai 2027.
Ensysce Biosciences (NASDAQ:ENSC) erhielt positives Feedback von der FDA zu PF614-MPAR, ihrem bahnbrechenden Opioid-Analgetikum mit eingebautem 脺berdosierungsschutz. Das Treffen mit der FDA am 23. Juli 2025 konzentrierte sich auf die Erlangung einer Kennzeichnung f眉r 脺berdosierungsschutz und best盲tigte die Berechtigung f眉r einen vereinfachten 505(b)(2)-Zulassungsweg.
PF614-MPAR, das die Breakthrough Therapy Designation der FDA erhalten hat, nutzt Ensysces propriet盲re TAAP鈩�- und MPAR庐-Technologien, um die Schmerzlinderung aufrechtzuerhalten und automatisch einen 脺berdosierungsschutz zu aktivieren, wenn die verschriebenen Dosen 眉berschritten werden. Die Entwicklung wird durch NIDA-Zusch眉sse bis Mai 2027 耻苍迟别谤蝉迟眉迟锄迟.
- Received FDA Breakthrough Therapy designation for PF614-MPAR
- Confirmed eligibility for accelerated 505(b)(2) regulatory pathway
- Secured NIDA grant funding through May 2027
- Potential expansion into opioid use disorder and ADHD treatments
- Additional clinical and non-clinical studies still required for approval
- Regulatory timeline for overdose protection labeling remains uncertain
Insights
FDA's positive feedback on PF614-MPAR significantly derisks Ensysce's breakthrough opioid with built-in overdose protection, advancing its path to potential approval.
Ensysce's announcement represents a significant regulatory milestone for PF614-MPAR, their opioid analgesic with built-in overdose protection. The FDA meeting has yielded three key outcomes that substantially advance this program: confirmation of a potential 505(b)(2) regulatory pathway, alignment on overdose protection labeling strategy, and establishment of a collaborative approach with the agency.
The 505(b)(2) pathway is particularly valuable as it allows Ensysce to leverage existing safety data for approved opioids, potentially reducing development time and costs significantly. This streamlined approach could accelerate time-to-market by eliminating the need for extensive duplicate studies that would be required under traditional approval pathways.
The company's dual-platform technology approach is scientifically notable. Their TAAP鈩� platform creates a prodrug that requires enzymatic activation in the digestive system, while the MPAR庐 technology appears designed to limit activation when multiple pills are consumed. This creates a ceiling effect mechanism that automatically restricts opioid release during potential overdose scenarios - addressing a critical safety gap in current pain management options.
The Breakthrough Therapy designation previously granted to PF614-MPAR further validates the clinical importance of this approach and provides additional regulatory advantages including intensive FDA guidance and eligibility for priority review.
Continued NIDA funding through 2027 provides important non-dilutive capital support for the program's development, reflecting ongoing federal interest in addressing the opioid crisis through innovative pharmaceutical approaches rather than just prescription limitations.
With opioid overdoses remaining a leading cause of accidental death in the US, a successful abuse-deterrent and overdose-protected opioid could significantly impact both patient safety and Ensysce's market position in the
~ Productive FDA Meeting Highlights Path Toward Overdose Protection Labeling and 505(b)(2) Regulatory Strategy ~
~ FDA and Ensysce Aligned on Collaborative Approach to Ensure Product's Full Safety Benefits are Recognized ~
SAN DIEGO, CA / / July 31, 2025 / (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical innovator focused on redefining opioid safety, today announced that it received positive feedback and constructive guidance from the U.S. Food and Drug Administration (FDA) on the development of PF614-MPAR, the Company's first-of-its-kind opioid analgesic designed with both abuse deterrence and overdose protection.
PF614-MPAR has earned the FDA's prestigious Breakthrough Therapy designation and is uniquely engineered using Ensysce's proprietary TAAP鈩� (Trypsin-Activated Abuse Protection) and MPAR庐 (Multi-Pill Abuse Resistance) technologies. These platforms are uniquely engineered to maintain powerful pain relief while automatically activating built-in overdose protection if a patient exceeds the prescribed dose-whether accidentally or intentionally.
The FDA meeting held July 23, 2025, focused on the clinical and non-clinical roadmap for PF614-MPAR's approval, with a key emphasis on achieving overdose protection labeling. Both Ensysce and the FDA aligned on a collaborative approach to ensure the product's safety benefits are appropriately recognized. This includes Ensysce working with the FDA to develop a whitepaper on Overdose Protection, while continuing to develop PF614-MPAR. The meeting provided guidance on non-clinical, clinical and manufacturing questions that the Company had posed to the agency, and it also confirmed that PF614-MPAR may be eligible to pursue a streamlined 505(b)(2) regulatory pathway, potentially accelerating its time to market.
"This milestone brings us closer than ever to delivering a new class of opioid analgesics that not only provide critical pain relief but also protect patients from the devastating risks of overdose," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "MPAR technology is designed to save lives. While we are initially applying it to opioid pain medications, we also see significant potential in addressing overdose risks in opioid use disorder and ADHD treatments. Our goal is to transform how medicines are designed so that the drugs in every household medicine cabinet are inherently safer."
Development of PF614-MPAR has been supported by two multi-year grants from the National Institute on Drug Abuse (NIDA)1, the most recent awarded in 2024 which continues to fund the program through May 2027.
1The research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UO1DA059791.
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庐) 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 .
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 . 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
[email protected]
SOURCE: Ensysce Biosciences
View the original on ACCESS Newswire
FAQ
What is Ensysce Biosciences' PF614-MPAR and how does it work?
What was the outcome of Ensysce's FDA meeting on July 23, 2025?
How is Ensysce Biosciences' PF614-MPAR development being funded?
What potential applications does Ensysce's MPAR technology have beyond pain medication?
What regulatory designations has ENSC's PF614-MPAR received from the FDA?
