Ensysce Biosciences Initiates Pivotal Phase 3 Study of PF614 - A Next-Generation Opioid - Designed to Deliver Powerful Pain Relief and Reduce Abuse
Ensysce Biosciences (NASDAQ:ENSC) has launched its pivotal Phase 3 study of PF614, a next-generation opioid designed for severe pain management with built-in abuse and overdose protection. The study, designated PF614-301, will evaluate the drug's efficacy and safety in treating moderate to severe pain following abdominoplasty.
The company has partnered with Rho, Inc., a clinical research organization with extensive CNS and pain study expertise, having managed over 90 neurology trials across 840 sites in the past five years. The study aims to demonstrate PF614's ability to provide effective post-surgical pain relief while offering a safer alternative to conventional opioids.
Ensysce Biosciences (NASDAQ:ENSC) ha avviato il suo studio pivotale di Fase 3 su PF614, un oppioide di nuova generazione progettato per la gestione del dolore severo con protezione integrata contro l'abuso e il sovradosaggio. Lo studio, denominato PF614-301, valuterà l'efficacia e la sicurezza del farmaco nel trattamento del dolore da moderato a severo dopo l'addominoplastica.
L'azienda ha collaborato con Rho, Inc., un'organizzazione di ricerca clinica con una vasta esperienza negli studi sul sistema nervoso centrale e sul dolore, avendo gestito oltre 90 trial neurologici in 840 sedi negli ultimi cinque anni. L'obiettivo dello studio è dimostrare la capacità di PF614 di offrire un sollievo efficace dal dolore post-operatorio, proponendo al contempo un'alternativa più sicura rispetto agli oppioidi tradizionali.
Ensysce Biosciences (NASDAQ:ENSC) ha iniciado su estudio pivotal de Fase 3 de PF614, un opioide de próxima generación diseñado para el manejo del dolor severo con protección incorporada contra el abuso y la sobredosis. El estudio, denominado PF614-301, evaluará la eficacia y seguridad del medicamento en el tratamiento del dolor de moderado a severo tras una abdominoplastia.
La compañía se ha asociado con Rho, Inc., una organización de investigación clínica con amplia experiencia en estudios de SNC y dolor, habiendo gestionado más de 90 ensayos neurológicos en 840 sitios durante los últimos cinco años. El objetivo del estudio es demostrar la capacidad de PF614 para proporcionar un alivio efectivo del dolor postquirúrgico, ofreciendo una alternativa más segura a los opioides convencionales.
Ensysce Biosciences (NASDAQ:ENSC)는 내장 남용 및 과다복용 방지 기능이 포함된 차세대 중증 통증 관리용 오피오이드 PF614의 중대한 3상 임상시험을 시작했습니다. PF614-301로 명명된 이번 연구는 복부 성형술 후 중등도에서 중증 통증 치료에 있어 약물의 효능과 안전성을 평가할 예정입니다.
회사는 지난 5년간 840개 기관에서 90건 이상의 신경학 임상을 관리해온 중추신경계 및 통증 연구 전문 임상 연구 기관 Rho, Inc.와 협력했습니다. 이번 연구는 PF614가 효과적인 수술 후 통증 완화를 제공하면서 기존 오피오이드보다 더 안전한 대안을 제시할 수 있음을 입증하는 것을 목표로 합니다.
Ensysce Biosciences (NASDAQ:ENSC) a lancé son étude pivot de Phase 3 sur PF614, un opioïde de nouvelle génération conçu pour la gestion de la douleur sévère avec une protection intégrée contre l'abus et le surdosage. L'étude, nommée PF614-301, évaluera l'efficacité et la sécurité du médicament dans le traitement de la douleur modérée à sévère après une abdominoplastie.
L'entreprise s'est associée à Rho, Inc., une organisation de recherche clinique spécialisée dans les études sur le système nerveux central et la douleur, ayant géré plus de 90 essais neurologiques sur 840 sites au cours des cinq dernières années. L'objectif de l'étude est de démontrer la capacité de PF614 à fournir un soulagement efficace de la douleur postopératoire tout en offrant une alternative plus sûre aux opioïdes conventionnels.
Ensysce Biosciences (NASDAQ:ENSC) hat seine entscheidende Phase-3-Studie von PF614 gestartet, einem Opioid der nächsten Generation, das für die Behandlung von starken Schmerzen mit integriertem Schutz vor Missbrauch und Überdosierung entwickelt wurde. Die Studie mit der Bezeichnung PF614-301 wird die Wirksamkeit und Sicherheit des Medikaments bei der Behandlung von mäßigen bis starken Schmerzen nach einer Bauchdeckenstraffung bewerten.
Das Unternehmen arbeitet mit Rho, Inc. zusammen, einer klinischen Forschungsorganisation mit umfangreicher Erfahrung in Studien zum zentralen Nervensystem und Schmerz, die in den letzten fünf Jahren über 90 neurologische Studien an 840 Standorten geleitet hat. Ziel der Studie ist es, die Fähigkeit von PF614 zu zeigen, wirksame postoperative Schmerzlinderung zu bieten und gleichzeitig eine sicherere Alternative zu herkömmlichen Opioiden darzustellen.
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Insights
Ensysce's PF614 enters pivotal Phase 3 testing - a critical milestone that significantly advances their abuse-deterrent opioid toward potential market approval.
The initiation of PF614's Phase 3 study represents a critical advancement in Ensysce's clinical development program. This milestone signals the company has successfully completed earlier clinical phases and received FDA protocol review clearance - essential regulatory hurdles that many drug candidates never reach. Phase 3 represents the final and most definitive stage of human testing before seeking FDA approval, typically involving hundreds to thousands of patients.
PF614 is being positioned as a next-generation opioid with a dual value proposition: providing effective pain management while incorporating abuse-deterrent properties. The specific trial design (randomized, double-blind, placebo- and active-controlled) represents the gold standard in clinical research methodology, which will provide robust comparative data against both placebo and current standard treatments.
The abdominoplasty pain model is particularly well-suited for evaluating analgesics, as it provides a standardized surgical procedure with predictable pain patterns. This approach allows for clearer efficacy signals and more straightforward regulatory interpretation of results.
Partnering with Rho Inc. brings significant operational expertise to the program. Their track record of 90+ neurology/psychiatry trials across 840+ sites suggests they have the necessary infrastructure and experience to execute this complex study efficiently. This partnership mitigates some execution risk that often affects small biotechs conducting pivotal trials.
If successful, PF614 could potentially address a significant medical need in pain management - effective analgesia with reduced abuse potential - in a market where concerns about opioid misuse have dramatically impacted prescribing patterns and patient access.
~ FDA Protocol Review Completed ~
~ Rho, Inc. Selected as Clinical Research Partner ~
SAN DIEGO, CA / ACCESS Newswire / July 16, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the initiation of its pivotal Phase 3 study of PF614, the Company's lead product candidate.
This landmark study, PF614-301, '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' is designed to demonstrate PF614's ability to effectively manage post-surgical pain while protecting from abuse and offering patients what is believed to be a safer alternative to conventional opioids. The study aims to confirm that PF614 delivers powerful pain relief and facilitates the transition to non-opioid out-patient care.
To execute this critical program, Ensysce has partnered with Rho, Inc., a leading Clinical Research Organization with extensive expertise in central nervous system (CNS) disorders and pain studies. Over the past five years, Rho has successfully managed more than 90 neurology and psychiatry trials at over 840 sites, guiding programs from first-in-human trials to regulatory approval - making them an ideal partner for Ensysce's transformative mission.
"In our view, this is more than a partnership. It's a coordinated effort to execute a pivotal study, and a significant step toward redefining pain therapy." said Dr. Lynn Kirkpatrick, CEO of Ensysce. "Our goal is to deliver a new class of opioids that delivers relief from severe pain while protecting patients from the dangers of abuse. We believe PF614 can set a new standard of safety for millions of patients who depend on these medications for a good quality of life."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage pharmaceutical company disrupting the pain treatment landscape with its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms. By engineering opioids with intrinsic safeguards against tampering, misuse, and overdose, Ensysce aims to offer safer, life-saving options for patients in need of powerful pain relief. Learn more at: 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.
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