Ensysce Biosciences CEO Dr. Lynn Kirkpatrick and Creighton University's Dr. Neel Pathak Discuss the Opioid Crisis and Next Generation Opioids
Ensysce Biosciences (NASDAQ: ENSC) CEO Dr. Lynn Kirkpatrick and Creighton University's Dr. Neel Pathak discussed innovative solutions to the opioid crisis in a Today's Marketplace interview. The company is developing next-generation opioids using 'clever chemistry' to address the needs of approximately 3 million annual patients requiring opioid pain management.
The company's approach involves chemically modifying oxycodone to make it inactive unless taken orally, reducing abuse potential. The medication includes built-in safeguards against overdose, preventing release if more than prescribed dosage is ingested, while maintaining pain relief efficacy.
The modified oxycodone has received both FDA Fast Track and Breakthrough Therapy designations, recognizing the medical need and improvement over existing therapies. This development addresses the dual challenges of providing necessary pain treatment while meeting regulatory requirements to restrict opioid use.
Ensysce Biosciences (NASDAQ: ENSC) CEO Dr. Lynn Kirkpatrick e il Dr. Neel Pathak della Creighton University hanno discusso soluzioni innovative per la crisi degli oppioidi in un'intervista di Today's Marketplace. L'azienda sta sviluppando oppioidi di nuova generazione utilizzando 'chimica intelligente' per soddisfare le esigenze di circa 3 milioni di pazienti all'anno che necessitano di gestione del dolore con oppioidi.
L'approccio dell'azienda prevede la modifica chimica dell'ossicodone per renderlo inattivo a meno che non venga assunto per via orale, riducendo il potenziale di abuso. Il medicinale include misure di sicurezza integrate contro il sovradosaggio, impedendo il rilascio se viene assunta una dose superiore a quella prescritta, mantenendo al contempo l'efficacia nel sollievo dal dolore.
L'ossicodone modificato ha ricevuto sia la designazione FDA Fast Track che quella di Breakthrough Therapy, riconoscendo il bisogno medico e il miglioramento rispetto alle terapie esistenti. Questo sviluppo affronta le sfide duali di fornire un trattamento necessario per il dolore mentre si soddisfano i requisiti normativi per limitare l'uso di oppioidi.
Ensysce Biosciences (NASDAQ: ENSC) CEO Dr. Lynn Kirkpatrick y el Dr. Neel Pathak de la Universidad de Creighton discutieron soluciones innovadoras para la crisis de los opioides en una entrevista de Today's Marketplace. La empresa está desarrollando opioides de nueva generación utilizando 'química inteligente' para abordar las necesidades de aproximadamente 3 millones de pacientes anuales que requieren manejo del dolor con opioides.
El enfoque de la empresa implica modificar químicamente el oxicodona para hacerlo inactivo a menos que se tome por vía oral, reduciendo el potencial de abuso. El medicamento incluye salvaguardias integradas contra sobredosis, impidiendo la liberación si se ingiere una dosis superior a la prescrita, mientras se mantiene la eficacia del alivio del dolor.
El oxicodona modificado ha recibido tanto designaciones de FDA Fast Track como de Breakthrough Therapy, reconociendo la necesidad médica y la mejora sobre las terapias existentes. Este desarrollo aborda los desafíos duales de proporcionar el tratamiento necesario para el dolor mientras se cumplen los requisitos regulatorios para restringir el uso de opioides.
Ensysce Biosciences (NASDAQ: ENSC)의 CEO인 Lynn Kirkpatrick 박사와 Creighton University의 Neel Pathak 박사가 Today's Marketplace 인터뷰에서 오피오이드 위기에 대한 혁신적인 솔루션을 논의했습니다. 회사는 '스마트 화학'을 사용하여 차세대 오피오이드를 개발하고 있습니다 이는 매년 약 300만 명의 환자가 오피오이드 통증 관리가 필요합니다.
회사의 접근 방식은 옥시코돈을 화학적으로 수정하여 구강으로 복용하지 않으면 비활성 상태가 되도록 하여 남용 가능성을 줄이는 것입니다. 이 약물은 과다 복용에 대한 내장된 안전 장치를 포함하고 있으며, 처방된 복용량 이상이 섭취되면 방출을 방지하면서 통증 완화의 효능을 유지합니다.
수정된 옥시코돈은 FDA의 Fast Track 및 Breakthrough Therapy 지정을 모두 받았으며, 이는 의학적 필요와 기존 치료법에 대한 개선을 인정받은 것입니다. 이 개발은 필요한 통증 치료를 제공하면서 오피오이드 사용을 제한하기 위한 규제 요건을 충족하는 이중 과제를 다룹니다.
Ensysce Biosciences (NASDAQ: ENSC) le PDG Dr. Lynn Kirkpatrick et le Dr. Neel Pathak de l'Université de Creighton ont discuté de solutions innovantes à la crise des opioïdes lors d'une interview de Today's Marketplace. L'entreprise développe des opioïdes de nouvelle génération en utilisant une 'chimie intelligente' pour répondre aux besoins d'environ 3 millions de patients par an nécessitant une gestion de la douleur par opioïdes.
L'approche de l'entreprise consiste à modifier chimiquement l'oxycodone pour le rendre inactif sauf s'il est pris par voie orale, réduisant ainsi le potentiel d'abus. Le médicament comprend des dispositifs de sécurité intégrés contre le surdosage, empêchant la libération si une dose supérieure à celle prescrite est ingérée, tout en maintenant l'efficacité du soulagement de la douleur.
L'oxycodone modifié a reçu à la fois les désignations Fast Track et Breakthrough Therapy de la FDA, reconnaissant le besoin médical et l'amélioration par rapport aux thérapies existantes. Ce développement répond aux doubles défis de fournir un traitement nécessaire de la douleur tout en respectant les exigences réglementaires pour restreindre l'utilisation des opioïdes.
Ensysce Biosciences (NASDAQ: ENSC) CEO Dr. Lynn Kirkpatrick und Dr. Neel Pathak von der Creighton University diskutierten in einem Interview mit Today's Marketplace innovative Lösungen für die Opioidkrise. Das Unternehmen entwickelt opioide der nächsten Generation, die 'clevere Chemie' nutzen, um den Bedürfnissen von etwa 3 Millionen Patienten pro Jahr gerecht zu werden, die eine Schmerzbehandlung mit Opioiden benötigen.
Der Ansatz des Unternehmens beinhaltet die chemische Modifikation von Oxycodon, um es inaktiv zu machen, es sei denn, es wird oral eingenommen, wodurch das Missbrauchspotenzial verringert wird. Das Medikament enthält integrierte Sicherheitsvorkehrungen gegen Überdosierung, die eine Freisetzung verhindern, wenn eine höhere als die verschriebene Dosis eingenommen wird, während die Wirksamkeit der Schmerzlinderung erhalten bleibt.
Das modifizierte Oxycodon hat sowohl die FDA Fast Track- als auch die Breakthrough Therapy-Designationen erhalten, die den medizinischen Bedarf und die Verbesserung gegenüber bestehenden Therapien anerkennen. Diese Entwicklung adressiert die doppelte Herausforderung, eine notwendige Schmerzbehandlung bereitzustellen und gleichzeitig die regulatorischen Anforderungen zur Einschränkung des Opioidgebrauchs zu erfüllen.
- FDA Fast Track and Breakthrough Therapy designations received
- Novel abuse-deterrent technology developed
- Addressing $1 trillion healthcare cost problem
- None.
Insights
Ensysce's dual-approach to opioid safety represents a significant technological differentiation in the abuse-deterrent formulation (ADF) space. The FDA's decision to grant both Fast Track and Breakthrough Therapy designations for their modified oxycodone is particularly noteworthy, as these designations are reserved for treatments addressing serious conditions with preliminary clinical evidence indicating substantial improvement over available therapies.
Their technology employs two distinct mechanisms: oral-only activation and overdose protection. This differs from most first-generation ADFs that relied primarily on physical barriers that could be circumvented. By chemically modifying the opioid molecule itself, Ensysce's approach potentially addresses fundamental limitations of earlier technologies.
The regulatory designations provide tangible benefits including more frequent FDA interactions, eligibility for accelerated approval and priority review, and a potentially compressed development timeline. For a micro-cap biotech like Ensysce (
What's missing from this announcement is clarity on the development stage - whether the product is in preclinical testing, early clinical trials, or later stages. This information is critical for estimating how long before potential commercialization. The opioid market remains substantial with 3 million patients annually requiring these medications, but obtaining insurance coverage and physician adoption for new ADFs has historically presented significant commercialization challenges.
The full interview can be viewed online here.
"[Unfortunately,] opioids are still being prescribed for pain because, for many patients, there still are no other alternatives available to meet their needs for relief of severe and chronic pain, such as post-acute surgical care, cancer care, palliative care, etc. Yet we all know that opioids come with severe risks as well. Still, there are about 3 million patients a year that have no choice but to rely on opioids."
Dr. Pathak went on to explain to King that those risks not only encompass health concerns like abuse and addiction but also have a serious economic impact, costing the healthcare industry almost
Dr. Kirkpatrick explained how Ensysce Biosciences is trying to change all that by introducing safer opioids.
"Our team uses what I like to call 'clever chemistry' to create the next generation of opioids," she told King. "The clever chemistry is designed to not only reduce abuse but to make these products safer, so patients in pain can have less fear and higher confidence level in taking opioid medications when they need them."
The pharmaceutical industry recognizes the opioid crisis in America. Whereas other companies have invested billions of dollars unsuccessfully trying to develop other forms of painkillers that are as effective as opioids, Dr. Kirkpatrick said her company has taken a different approach -- which is to re-engineer opioids so that doctors can be confident prescribing and patients more comfortable taking.
Dr. Kirkpatrick further clarifies, "[To date] there are no products on the market that can surpass the pain relief of opioids. We are chemically modifying opioids, making them inactive unless they are taken orally, which significantly cuts down the chances of abuse."
That "clever" chemical engineering also includes built-in safeguards against overdose that prevent the medication from being released if more than the prescribed dosage is ingested. All of this while still making the drug – in this case, oxycodone – still effective as always in alleviating pain.
"This is great because now we have a biological way to prevent abuse and increase patient confidence," says Dr. Pathak.
Kirkpatrick said that their chemically modified oxycodone has received FDA "Fast Track" as well as "Breakthrough Therapy" designation, which means the agency recognizes the "medical need" for this kind of product as well as the improvement over available therapies and is doing its best to expedite its availability to the public.
TMP's interviews cover important business topics and solutions with insights from academic experts and business leaders. Dr. Kirkpatrick said her appearance on TMP was a great way to get her company's vision across to a national audience. "TMP provides a perfect platform to be able to discuss the dueling crises in America today, the needs of millions of Americans for opioid pain treatment to function daily versus the regulations that have been put in place to restrict opioid use. Ensysce is pleased that their approach may be able to break this impasse."
About Ensysce Biosciences
Ensysce is a developer of first-in-class, uniquely innovative solutions in oral drug delivery. Their proprietary TAAP™ and MPAR® technologies improve the care and safety of patients by preventing the possibility of both abuse and overdose of prescription drugs. Learn more by visiting ensysce.com.
About Creighton University
Creighton University is a Jesuit, Catholic university located in
About Today's Marketplace
Today's Marketplace (TMP) is a series of C-Suite interviews filmed at the prestigious New York Stock Exchange (NYSE) and the NASDAQ MarketSite studio for earned media distribution. TMP's multi-channel distribution provides robust authoritative and credible media exposure to under-reported stories. Visit TMP at todaysmarketplace.tv
Media Contact:
Diane Rygh; producers@cmghd.com
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FAQ
What innovative technology is Ensysce Biosciences (ENSC) developing for opioid safety?
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How many patients annually require opioid treatment according to Ensysce (ENSC)?
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