Ensysce Biosciences Announces Positive Data from Opioid Overdose Protection Study
Ensysce Biosciences (NASDAQ:ENSC) has announced positive results from Part 1 of its second clinical trial evaluating PF614-MPAR for opioid overdose protection. The study demonstrated that their combined TAAP and MPAR technologies can effectively deliver pain relief while protecting against overdose risks.
The trial confirmed that a 100 mg dosage of PF614-MPAR successfully delivers oxycodone for severe pain treatment while providing overdose protection at higher-than-prescribed doses. When subjects took three or more doses simultaneously, the maximum oxycodone release (Cmax) was reduced compared to unprotected PF614, with greater protection observed at five doses. No unexpected adverse events were reported.
The study will proceed with Part 2 to examine food effects and Part 3 to evaluate repeat dosing. PF614-MPAR is currently the only opioid product with FDA's Breakthrough Therapy designation. The company plans to discuss the complete analysis with the FDA regarding full development plans for commercialization.
Ensysce Biosciences (NASDAQ:ENSC) ha annunciato risultati positivi dalla Parte 1 del suo secondo trial clinico che valuta PF614-MPAR per la protezione da overdose da oppioidi. Lo studio ha dimostrato che le loro tecnologie combinate TAAP e MPAR possono fornire efficacemente sollievo dal dolore proteggendo al contempo dai rischi di overdose.
Il trial ha confermato che una dose di 100 mg di PF614-MPAR somministra con successo ossicodone per il trattamento del dolore severo, garantendo protezione da overdose anche a dosi superiori a quelle prescritte. Quando i soggetti hanno assunto tre o più dosi contemporaneamente, il rilascio massimo di ossicodone (Cmax) è stato ridotto rispetto a PF614 non protetto, con una protezione maggiore osservata a cinque dosi. Non sono stati segnalati eventi avversi inattesi.
Lo studio proseguirà con la Parte 2 per esaminare l’effetto del cibo e la Parte 3 per valutare la somministrazione ripetuta. PF614-MPAR è attualmente l’unico prodotto oppioide ad aver ricevuto la designazione Breakthrough Therapy dalla FDA. L’azienda prevede di discutere l’analisi completa con la FDA riguardo ai piani di sviluppo completi per la commercializzazione.
Ensysce Biosciences (NASDAQ:ENSC) ha anunciado resultados positivos de la Parte 1 de su segundo ensayo clínico que evalúa PF614-MPAR para la protección contra sobredosis de opioides. El estudio demostró que sus tecnologías combinadas TAAP y MPAR pueden administrar eficazmente alivio del dolor mientras protegen contra los riesgos de sobredosis.
El ensayo confirmó que una dosis de 100 mg de PF614-MPAR entrega con éxito oxicodona para el tratamiento del dolor severo, proporcionando protección contra sobredosis incluso a dosis superiores a las prescritas. Cuando los sujetos tomaron tres o más dosis simultáneamente, la liberación máxima de oxicodona (Cmax) se redujo en comparación con PF614 sin protección, observándose mayor protección con cinco dosis. No se reportaron eventos adversos inesperados.
El estudio continuará con la Parte 2 para examinar los efectos de los alimentos y la Parte 3 para evaluar la dosificación repetida. PF614-MPAR es actualmente el único producto opioide con la designación Breakthrough Therapy de la FDA. La compañía planea discutir el análisis completo con la FDA respecto a los planes completos de desarrollo para la comercialización.
Ensysce Biosciences (NASDAQ:ENSC)는 오피오이드 과다복용 보호를 위한 PF614-MPAR의 두 번째 임상시험 1부에서 긍정적인 결과를 발표했습니다. 연구 결과, TAAP와 MPAR 기술의 결합이 통증 완화를 효과적으로 제공하면서 과다복용 위험으로부터 보호할 수 있음을 입증했습니다.
임상시험에서는 100mg 용량의 PF614-MPAR가 심한 통증 치료를 위해 옥시코돈을 성공적으로 전달하면서 처방량을 초과하는 복용 시에도 과다복용 보호 기능을 제공하는 것으로 확인되었습니다. 대상자가 세 번 이상 동시에 복용했을 때, 최대 옥시코돈 방출량(Cmax)이 보호되지 않은 PF614보다 감소했으며, 다섯 번 복용 시 더 큰 보호 효과가 관찰되었습니다. 예상치 못한 이상 반응은 보고되지 않았습니다.
연구는 2부에서 음식 섭취 영향, 3부에서 반복 투여 평가를 진행할 예정입니다. PF614-MPAR는 현재 FDA의 획기적 치료제(Breakthrough Therapy) 지정된 유일한 오피오이드 제품입니다. 회사는 상업화를 위한 전체 개발 계획과 관련해 FDA와 완전한 분석 결과를 논의할 계획입니다.
Ensysce Biosciences (NASDAQ:ENSC) a annoncé des résultats positifs de la Partie 1 de son deuxième essai clinique évaluant PF614-MPAR pour la protection contre les surdoses d’opioïdes. L’étude a démontré que leurs technologies combinées TAAP et MPAR peuvent délivrer efficacement un soulagement de la douleur tout en protégeant contre les risques de surdose.
L’essai a confirmé qu’une dose de 100 mg de PF614-MPAR permet d’administrer avec succès de l’oxycodone pour le traitement de douleurs sévères tout en offrant une protection contre la surdose à des doses supérieures à celles prescrites. Lorsque les sujets ont pris trois doses ou plus simultanément, la concentration maximale d’oxycodone (Cmax) a été réduite par rapport à PF614 non protégé, avec une protection accrue observée à cinq doses. Aucun effet indésirable inattendu n’a été signalé.
L’étude se poursuivra avec la Partie 2 pour examiner les effets de l’alimentation et la Partie 3 pour évaluer la répétition des doses. PF614-MPAR est actuellement le seul produit opioïde à bénéficier de la désignation Breakthrough Therapy de la FDA. La société prévoit de discuter de l’analyse complète avec la FDA concernant les plans de développement complets pour la commercialisation.
Ensysce Biosciences (NASDAQ:ENSC) hat positive Ergebnisse aus Teil 1 seiner zweiten klinischen Studie zur Bewertung von PF614-MPAR zum Schutz vor Opioid-Überdosierung bekannt gegeben. Die Studie zeigte, dass ihre kombinierten TAAP- und MPAR-Technologien wirksam Schmerz lindern können und gleichzeitig vor Überdosierungsrisiken schützen.
Die Studie bestätigte, dass eine 100 mg-Dosis von PF614-MPAR Oxycodon zur Behandlung starker Schmerzen erfolgreich abgibt und dabei auch bei höheren als den verschriebenen Dosen Schutz vor Überdosierung bietet. Wenn Probanden drei oder mehr Dosen gleichzeitig einnahmen, wurde die maximale Oxycodon-Freisetzung (Cmax) im Vergleich zu ungeschütztem PF614 reduziert, wobei bei fünf Dosen ein noch größerer Schutz beobachtet wurde. Es wurden keine unerwarteten Nebenwirkungen gemeldet.
Die Studie wird mit Teil 2 fortgesetzt, um die Auswirkungen von Nahrungsaufnahme zu untersuchen, und mit Teil 3, um wiederholte Dosierungen zu bewerten. PF614-MPAR ist derzeit das einzige Opioid-Produkt mit der Breakthrough-Therapy-Designation der FDA. Das Unternehmen plant, die vollständige Analyse mit der FDA zu besprechen, um die vollständigen Entwicklungspläne für die Kommerzialisierung zu klären.
- Clinical trial demonstrated successful overdose protection mechanism
- No unexpected adverse events reported in the safety data
- Only opioid product with FDA's Breakthrough Therapy designation
- Successful demonstration of protection across full dosage range planned for commercialization
- Additional clinical trial phases still pending completion (Parts 2 and 3)
- FDA approval still required before commercialization
Insights
Ensysce's PF614-MPAR data represents a significant advancement in opioid safety technology. The clinical results from Part 1 of study PF614-MPAR-102 demonstrated clear dose-dependent overdose protection - when subjects took three or more 100mg doses simultaneously, the maximum oxycodone released (Cmax) was measurably lower than with unprotected PF614. The protection mechanism showed increasing effectiveness with higher overdose attempts (five doses showed greater protection than three).
This technology combines two proprietary platforms - TAAP™ and MPAR® - to create a dual-mechanism safety profile that allows therapeutic pain relief at prescribed doses while limiting oxycodone release during overdose scenarios. The clean safety profile (no unexpected adverse events) further validates this approach.
What makes this particularly noteworthy is that these results, combined with their previous PF614-MPAR-101 study, now demonstrate overdose protection across the full planned commercial dosage range - a critical milestone for regulatory pathway discussions. The FDA's prior Breakthrough Therapy designation acknowledges this product addresses a serious unmet need in pain management.
The company's progression to Parts 2 and 3 (food effect and repeat dosing) completes the pharmacokinetic profile needed for final formulation decisions. This methodical approach through their clinical program substantiates that Ensysce has developed what could be the first opioid with built-in biochemical overdose protection - a potential paradigm shift in prescription opioid safety.
~ Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study ~
SAN DIEGO, CA / ACCESS Newswire / April 15, 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 opioid abuse and overdose, today announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection. PF614-MPAR-102 demonstrated that the combined Ensysce TAAPTM and MPAR® technologies can deliver strong relief for severe pain yet protect from the risk of excessive doses when consumed accidentally or deliberately.
Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed. Subjects were studied as their own control and received up to five 100 mg doses of the overdose-protected PF614-MPAR versus the unprotected PF614. The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time (Cmax) was reduced compared to that released following the consumption of same amount of PF614 alone, evidence of overdose protection. When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR.
We believe this data, combined with that from a previous study, PF614-MPAR-101, demonstrates overdose protection across the full dosage range of PF614-MPAR planned for commercialization. This complete analysis will be discussed with the FDA in an upcoming meeting focusing on the full development plans for PF614-MPAR.
The trial will now continue to enroll Part 2 to examine potential food effect and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR. The aggregate data will allow the Company to focus on perfecting a final drug product to move into commercialization.
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "These clinical data demonstrate that MPAR® is a vital tool to limit overdoses from prescription medications. Our initial study demonstrated the unique overdose protection built into PF614-MPAR, which is the only opioid product to have been granted FDA's Breakthrough Therapy designation. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is now closer to the finish line."
Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "Each phase of our MPAR related clinical studies thus far have provided highly encouraging data supporting the safety features of PF614 and PF614-MPAR that other opioids don't have. We are continuing to quickly execute the final stages of this study with Quotient Sciences and their Translational Pharmaceutics® platform, and we are working with a commercial manufacturing partner to prepare this unique product for the market. We look forward to productive discussions with the FDA to establish our path to registration for the first overdose-protected opioid."
PF614-MPAR 102 Clinical Study Description
Clinical study PF614-MPAR-102, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 Capsule is Co‑Administered with Nafamostat as a Combination of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination.
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
View the original press release on ACCESS Newswire
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