Ensysce Biosciences Submits Phase 3 Protocol to the FDA
Ensysce Biosciences (NASDAQ:ENSC) has submitted its Phase 3 protocol to the FDA for PF614, a novel opioid designed to treat moderate to severe post-surgical pain. The study, PF614-301, will evaluate the efficacy and safety of PF614 compared to placebo and an active comparator in patients undergoing abdominoplasty. Key features of PF614 include:
1. Longer-lasting pain relief (twice the duration of OxyContin)
2. Reduced abuse potential
3. Potential to address breakthrough pain between doses
The company expects to conduct the trial across 4-6 U.S. clinical sites, with results anticipated in late 2025. This submission marks a significant milestone in PF614's development as a 'next-generation opioid' for short-term severe pain management.
Ensysce Biosciences (NASDAQ:ENSC) ha presentato il suo protocollo di Fase 3 alla FDA per PF614, un nuovo oppioide progettato per trattare il dolore post-operatorio da moderato a severo. Lo studio, PF614-301, valuterà l'efficacia e la sicurezza di PF614 rispetto al placebo e a un comparatore attivo in pazienti sottoposti a addominoplastica. Le caratteristiche principali di PF614 includono:
1. Sollievo dal dolore di lunga durata (il doppio rispetto a OxyContin)
2. Potenziale di abuso ridotto
3. Capacità di trattare il dolore acuto tra le dosi
L'azienda prevede di condurre la sperimentazione in 4-6 centri clinici negli Stati Uniti, con risultati attesi per la fine del 2025. Questa presentazione segna un traguardo significativo nello sviluppo di PF614 come 'oppioide di nuova generazione' per la gestione del dolore severo a breve termine.
Ensysce Biosciences (NASDAQ:ENSC) ha presentado su protocolo de Fase 3 a la FDA para PF614, un nuevo opioide diseñado para tratar el dolor postoperatorio moderado a severo. El estudio, PF614-301, evaluará la eficacia y seguridad de PF614 en comparación con un placebo y un comparador activo en pacientes sometidos a abdominoplastia. Las características clave de PF614 incluyen:
1. Alivio del dolor de mayor duración (el doble que OxyContin)
2. Potencial de abuso reducido
3. Posibilidad de abordar el dolor de ruptura entre dosis
La compañía espera llevar a cabo el ensayo en 4-6 sitios clínicos en EE. UU., con resultados anticipados para finales de 2025. Esta presentación marca un hito significativo en el desarrollo de PF614 como un 'opioide de nueva generación' para el manejo del dolor severo a corto plazo.
Ensysce Biosciences(NASDAQ:ENSC)는 PF614에 대한 3상 시험 프로토콜을 FDA에 제출했습니다. PF614는 중등도에서 심각한 수술 후 통증을 치료하기 위한 새로운 오피오이드입니다. 이 연구(PF614-301)는 복부 성형술을 받은 환자에서 PF614의 효능과 안전성을 위약 및 활성 비교군과 비교하여 평가할 것입니다. PF614의 주요 특징은 다음과 같습니다:
1. 더 긴 통증 완화 지속 시간(옥시콘틴의 두 배)
2. 남용 가능성 감소
3. 투여 간 심한 통증에 대처할 가능성
회사는 미국 내 4-6개 임상 사이트에서 시험을 진행할 계획이며 결과는 2025년 말에 예상하고 있습니다. 이 제출은 PF614의 '차세대 오피오이드'로서 단기 심각한 통증 관리에 대한 개발의 중요한 이정표를 의미합니다.
Ensysce Biosciences (NASDAQ:ENSC) a soumis son protocole de phase 3 à la FDA pour PF614, un nouvel opioïde conçu pour traiter le douleur postopératoire modérée à sévère. L'étude, PF614-301, évaluera l'efficacité et la sécurité de PF614 par rapport à un placebo et à un comparateur actif chez les patients subissant une abdominoplastie. Les caractéristiques clés de PF614 comprennent :
1. Soulagement de la douleur prolongé (deux fois plus long que l'OxyContin)
2. Potentiel d'abus réduit
3. Capacité à traiter la douleur de rupture entre les doses
L'entreprise prévoit de mener l'essai dans 4 à 6 sites cliniques aux États-Unis, avec des résultats attendus pour fin 2025. Cette soumission représente une étape importante dans le développement de PF614 en tant qu'« opioïde de nouvelle génération » pour le traitement à court terme de la douleur sévère.
Ensysce Biosciences (NASDAQ:ENSC) hat sein Phase-3-Protokoll bei der FDA für PF614 eingereicht, ein neuartiges Opioid zur Behandlung von mäßigen bis schweren postoperativen Schmerzen. Die Studie PF614-301 wird die Wirksamkeit und Sicherheit von PF614 im Vergleich zu einem Placebo und einem aktiven Vergleichsprodukt bei Patienten, die sich einer Bauchstraffung unterziehen, bewerten. Zu den Hauptmerkmalen von PF614 zählen:
1. Länger anhaltende Schmerztherapie (doppelt so lang wie OxyContin)
2. Geringeres Missbrauchspotenzial
3. Möglichkeit zur Behandlung von Durchbruchschmerzen zwischen den Dosen
Das Unternehmen plant, die Studie an 4-6 klinischen Standorten in den USA durchzuführen, mit Ergebnissen, die für Ende 2025 erwartet werden. Diese Einreichung stellt einen bedeutenden Meilenstein in der Entwicklung von PF614 als 'Opioid der nächsten Generation' für das Management von kurzfristigen schweren Schmerzen dar.
- Submission of Phase 3 protocol to FDA for PF614, advancing the drug's development
- PF614 offers twice the duration of pain relief compared to OxyContin
- Potential for reduced abuse and overdose risk compared to existing opioids
- Addresses the issue of breakthrough pain between doses
- Phase 3 results expected in late 2025, potentially leading to market entry
- Phase 3 trial results not expected until late 2025, delaying potential market entry
- Regulatory approval still pending, with potential for setbacks or delays
- Competition from existing pain management solutions in the market
Insights
The submission of the Phase 3 protocol for PF614 to the FDA marks a significant milestone in Ensysce's clinical development program. This study, focusing on post-surgical pain management, could potentially reshape the opioid landscape if successful. Key points to consider:
- The trial's design as a multicenter, randomized, double-blind study with both placebo and active controls adds robustness to the methodology.
- PF614's reported longer duration of action (
2x that of OxyContin) could address the critical issue of breakthrough pain, potentially improving patient outcomes and reducing overall opioid consumption. - The inclusion of an active comparator will provide valuable data on PF614's efficacy relative to existing treatments, which is important for market positioning.
However, investors should note that Phase 3 trials are costly and time-consuming, with results not expected until late 2025. This timeline suggests a long runway to potential commercialization, requiring substantial financial resources in the interim.
From a financial perspective, this development carries several implications for Ensysce Biosciences:
- Potential market opportunity: The post-surgical pain management market is substantial, with opioids being a key player. A successful Phase 3 trial could position Ensysce to capture a significant share of this market.
- R&D expenses: Investors should anticipate increased R&D spending as the company progresses through this costly Phase 3 trial. This may impact short-term financials but is necessary for long-term value creation.
- Partnerships and funding: The advancement to Phase 3 might attract potential partners or additional funding, which could be important for sustaining operations through the extended development timeline.
While the news is positive for Ensysce's pipeline progress, it's important to note that the company's financial stability and cash runway will be critical factors to monitor as they navigate this expensive late-stage development phase.
Ensysce's progress with PF614 is noteworthy in the context of the ongoing opioid crisis. The pharmaceutical industry is under intense pressure to develop safer pain management solutions and PF614's potential benefits align well with these demands:
- Reduced abuse potential: This is a critical feature that could differentiate PF614 from traditional opioids, potentially leading to preferred status among prescribers and payers.
- Extended duration: The reported
2x longer lasting effect compared to OxyContin could significantly improve patient compliance and reduce the risk of addiction associated with more frequent dosing. - Market positioning: If approved, PF614 could be positioned as a premium product in the pain management space, potentially commanding higher prices and better margins.
However, regulatory scrutiny for new opioid products remains intense. Ensysce will need to demonstrate a compelling safety profile and clear advantages over existing treatments to secure FDA approval and subsequent market adoption.
Phase 3 Study to Assess PF614 Efficacy in Treating Post-Surgical Pain
SAN DIEGO, CA / ACCESSWIRE / September 19, 2024 / 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 it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA.
The study, once finalized with the FDA, will be conducted through four to six clinical sites in the United States, and is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Additionally, Ensysce will evaluate PF614 versus an active comparator, the use of rescue medication and the safety and tolerability of PF614.
Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "The review of this study protocol represents another key milestone that brings us one step closer to executing the last clinical phase of evaluation for PF614. We anticipate the results of this Phase 3 trial will continue to prove the positive qualities of PF614 over existing oxycodone products. We remain dedicated to bringing PF614, a ‘next-generation opioid', to market."
Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, "We believe that the features of PF614 will be a game changer for the treatment of short-term severe pain. The fact that PF614 delivers the pain-relieving qualities of OxyContin but lasts twice as long, should alleviate the common problem of recurring breakthrough pain between dosing. In parallel with its reduced abuse potential, PF614 is anticipated to offer this market a superior pain product. We look forward to conducting this trial and expect results in late 2025."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. 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. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. 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 accesswire.com
FAQ
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