FDA Grants Nutriband Meeting Request for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch
Nutriband (NASDAQ:NTRB) has secured a Type C Meeting with the FDA for its AVERSA™ FENTANYL, a pioneering abuse-deterrent fentanyl transdermal system. The virtual meeting, scheduled for September 18, 2025, will focus on Chemistry, Manufacturing, and Controls (CMC) plans from IND submission through 505(b)(2) NDA approval.
The company is collaborating with Kindeva to combine Nutriband's AVERSA™ abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. The product aims to be the world's first abuse-deterrent opioid patch, with projected peak annual US sales of $80-200 million. The technology is protected by patents in 46 countries, including major markets worldwide.
Nutriband (NASDAQ:NTRB) ha ottenuto un incontro di tipo C con la FDA per il suo AVERSA™ FENTANYL, un innovativo sistema transdermico di fentanyl con tecnologia deterrente all'abuso. L'incontro virtuale, previsto per il 18 settembre 2025, si concentrerà sui piani di Chimica, Produzione e Controlli (CMC) dalla presentazione dell'IND fino all'approvazione NDA 505(b)(2).
L'azienda sta collaborando con Kindeva per integrare la tecnologia deterrente all'abuso AVERSA™ di Nutriband con il cerotto di fentanyl approvato dalla FDA di Kindeva. Il prodotto punta a diventare il primo cerotto opioidico al mondo con tecnologia deterrente all'abuso, con vendite annue USA previste al picco tra 80 e 200 milioni di dollari. La tecnologia è protetta da brevetti in 46 paesi, inclusi i principali mercati globali.
Nutriband (NASDAQ:NTRB) ha asegurado una reunión de Tipo C con la FDA para su AVERSA™ FENTANYL, un sistema transdérmico de fentanilo pionero con tecnología para prevenir el abuso. La reunión virtual, programada para el 18 de septiembre de 2025, se centrará en los planes de Química, Manufactura y Controles (CMC) desde la presentación del IND hasta la aprobación de la NDA 505(b)(2).
La compañía está colaborando con Kindeva para combinar la tecnología disuasoria de abuso AVERSA™ de Nutriband con el parche de fentanilo aprobado por la FDA de Kindeva. El producto aspira a ser el primer parche opioide con tecnología para prevenir el abuso en el mundo, con ventas anuales máximas proyectadas en EE.UU. de 80 a 200 millones de dólares. La tecnología está protegida por patentes en 46 países, incluidos los principales mercados globales.
Nutriband (NASDAQ:NTRB)는 혁신적인 남용 방지 펜타닐 경피 시스템인 AVERSA™ FENTANYL에 대해 FDA와 유형 C 미팅을 확보했습니다. 이 가상 미팅은 2025년 9월 18일에 예정되어 있으며, IND 제출부터 505(b)(2) NDA 승인까지의 화학, 제조 및 관리(CMC) 계획에 중점을 둘 예정입니다.
회사는 Kindeva와 협력하여 Nutriband의 AVERSA™ 남용 방지 기술을 Kindeva의 FDA 승인 펜타닐 패치와 결합하고 있습니다. 이 제품은 세계 최초의 남용 방지 오피오이드 패치가 되는 것을 목표로 하며, 미국 내 연간 최대 매출은 8천만 달러에서 2억 달러로 예상됩니다. 이 기술은 주요 글로벌 시장을 포함한 46개국에서 특허로 보호받고 있습니다.
Nutriband (NASDAQ:NTRB) a obtenu une réunion de type C avec la FDA pour son AVERSA™ FENTANYL, un système transdermique de fentanyl innovant doté d'une technologie de prévention de l'abus. La réunion virtuelle, prévue pour le 18 septembre 2025, portera sur les plans de Chimie, Fabrication et Contrôles (CMC) depuis la soumission de l'IND jusqu'à l'approbation du NDA 505(b)(2).
L'entreprise collabore avec Kindeva pour associer la technologie de prévention de l'abus AVERSA™ de Nutriband au patch de fentanyl approuvé par la FDA de Kindeva. Ce produit vise à devenir le premier patch opioïde au monde doté d'une technologie anti-abus, avec des ventes annuelles maximales prévues aux États-Unis entre 80 et 200 millions de dollars. La technologie est protégée par des brevets dans 46 pays, incluant les principaux marchés mondiaux.
Nutriband (NASDAQ:NTRB) hat ein Type-C-Meeting mit der FDA für sein AVERSA™ FENTANYL gesichert, ein bahnbrechendes fentanyltransdermales System mit Missbrauchsverhinderungstechnologie. Das virtuelle Treffen, geplant für den 18. September 2025, wird sich auf die Pläne für Chemie, Herstellung und Kontrolle (CMC) vom IND-Einreichung bis zur 505(b)(2) NDA-Zulassung konzentrieren.
Das Unternehmen arbeitet mit Kindeva zusammen, um Nutribands AVERSA™-Missbrauchsverhinderungstechnologie mit dem von der FDA zugelassenen Fentanyl-Pflaster von Kindeva zu kombinieren. Das Produkt soll das weltweit erste Missbrauchsverhinderungs-Opioidpflaster werden, mit prognostizierten Jahresumsätzen in den USA von 80 bis 200 Millionen US-Dollar. Die Technologie ist durch Patente in 46 Ländern geschützt, einschließlich der wichtigsten globalen Märkte.
- Potential to be first-to-market with abuse-deterrent opioid patch technology
- Projected peak annual US sales of $80-200 million
- Strong intellectual property protection with patents in 46 countries
- Partnership with Kindeva leveraging their FDA-approved fentanyl patch
- Global market expansion potential beyond US
- Product still requires full regulatory approval pathway including IND and NDA submissions
- Significant timeline to commercialization with multiple regulatory steps ahead
- Market success dependent on FDA approval and adoption in competitive pain management space
Insights
FDA granting Type C Meeting for Nutriband's AVERSA FENTANYL represents significant regulatory progress toward commercializing this novel abuse-deterrent opioid patch.
The FDA's agreement to hold a Type C Meeting for Nutriband's AVERSA FENTANYL signifies a meaningful regulatory milestone in the development pathway. This meeting, scheduled for September 18, 2025, specifically focuses on Chemistry, Manufacturing, and Controls (CMC) plans - a critical component of any drug approval process that addresses how the product will be consistently manufactured to quality standards.
The meeting's purpose is particularly significant as it spans the entire regulatory journey from IND submission through 505(b)(2) NDA approval to commercialization. This comprehensive approach suggests the FDA recognizes the potential public health value of an abuse-deterrent fentanyl patch and is providing guidance to facilitate development.
The 505(b)(2) regulatory pathway mentioned is strategically important, as it allows Nutriband to leverage existing safety and efficacy data from Kindeva's FDA-approved fentanyl patch, potentially streamlining the approval process. This partnership combines Nutriband's proprietary abuse-deterrent technology with an already-validated delivery system.
From a market perspective, the estimated
The AVERSA technology's approach of incorporating aversive agents into transdermal patches addresses a critical gap in current pain management options. If successful, this would represent the first abuse-deterrent opioid patch, providing physicians with an important new option for managing severe pain while potentially reducing risks of diversion, misuse, and accidental exposure.
FDA grants meeting for AVERSA™ FENTANYL (abuse deterrent transdermal system) to provide feedback on the Chemistry, Manufacturing, and Controls plans for the product through commercialization.
Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
ORLANDO, Fla., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Food and Drug Administration (US FDA) has granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). The purpose of the meeting is to specifically provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA) and subsequent commercialization.
The meeting is scheduled as a virtual face-to-face meeting to be held on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).
Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them.
AVERSA FENTANYL has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA FENTANYL has the potential to reach peak annual US sales of
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
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1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.
About Kindeva
At Kindeva, we manufacture more tomorrows for patients worldwide. With best-in-class facilities and comprehensive CDMO services, we offer more than manufacturing—we deliver strategic value. Our global network of 10 manufacturing and R&D sites offer exceptional integrated knowledge and capabilities, including Annex 1-compliant state-of-the-art aseptic fill finish capacity and next-generation sustainable inhalation propellant technology. By combining expertise in injectable, pulmonary, nasal and dermal drug delivery, we help meet the demands of today and deliver the possibilities of tomorrow. Find out more at https://www.kindevadd.com.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Contact Information:
Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com
SOURCE: Nutriband Inc.
FAQ
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