Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch
Nutriband (NASDAQ:NTRB) received final meeting minutes from a Sept 18, 2025 virtual face-to-face meeting with the US FDA regarding its lead product AVERSA™ FENTANYL, an abuse-deterrent fentanyl transdermal system. FDA confirmed the regulatory pathway as a 505(b)(2) NDA and provided CMC feedback on registration batch plans, manufacturing process validation, product specifications, stability testing, and planned Category 1 in vitro manipulation/extraction studies. Nutriband is incorporating FDA guidance as it advances toward an IND filing to support a Human Abuse Potential (HAP) clinical study. The company partners with Kindeva and cites a peak US sales potential of $80M–$200M. Nutriband holds patents in 46 countries.
Nutriband (NASDAQ:NTRB) ha ricevuto i verbali finali dalla riunione virtuale faccia-a-face del 18 settembre 2025 con la US FDA riguardo al suo lead product AVERSA™ FENTANYL, un sistema transdermale fentanyl con deterrente all'abuso. La FDA ha confermato il percorso regolatorio come una NDA 505(b)(2) e ha fornito feedback sulla CMC riguardo i piani di lotti di registrazione, la convalida del processo di produzione, le specifiche di prodotto, i test di stabilità e gli studi pianificati di manipolazione/estrazione in vitro di Categoria 1. Nutriband sta incorporando le indicazioni della FDA mentre procede verso una IND filing per supportare uno studio clinico sul potenziale di abuso umano (HAP). L'azienda si è assicurata una partnership con Kindeva e cita un potenziale picco di vendite negli Stati Uniti di $80M–$200M. Nutriband detiene brevetti in 46 paesi.
Nutriband (NASDAQ:NTRB) recibió las actas finales de la reunión virtual cara a cara del 18 de septiembre de 2025 con la FDA de EE. UU. con respecto a su producto principal AVERSA™ FENTANYL, un sistema transdérmico de fentanilo con disuasión de abuso. La FDA confirmó la vía regulatoria como una NDA 505(b)(2) y proporcionó comentarios de CMC sobre los planes de lotes de registro, la validación del proceso de fabricación, las especificaciones del producto, las pruebas de estabilidad y los estudios planificados de manipulación/extracción in vitro de la Categoría 1. Nutriband está incorporar las orientaciones de la FDA a medida que avanza hacia una presentación IND para respaldar un estudio clínico de Potencial de Abuso Humano (HAP). La empresa se asocia con Kindeva y cita un potencial de ventas máximo en EE. UU. de $80M–$200M. Nutriband posee patentes en 46 países.
Nutriband (NASDAQ:NTRB)은(는) 2025년 9월 18일의 FDA와의 가상 대면 회의에서 주력 제품 AVERSA™ FENTANYL, 남용 억제 패치형 펜타닐 시스템에 대한 최종 회의록을 받았습니다. FDA는 규제 경로를 505(b)(2) NDA로 확인했고 등록 배치 계획, 제조 공정 검증, 제품 사양, 안정성 시험 및 예비 1류 체외 조작/추출 연구와 관련한 CMC 피드백을 제공했습니다. Nutriband는 FDA 지침을 반영하여 인간 남용 가능성(HAP) 임상 연구를 지원하기 위한 IND 제출을 향해 나아가고 있습니다. 이 회사는 Kindeva와 협력하며 미국 매출 잠재 상한으로 $80M–$200M를 인용합니다. Nutriband는 46개국에서 특허를 보유하고 있습니다.
Nutriband (NASDAQ:NTRB) a reçu les procès-verbaux finaux de la réunion virtuelle en face-à-face du 18 septembre 2025 avec la FDA américaine concernant son produit principal AVERSA™ FENTANYL, un système transdermique à fentanyl dissuadant l'abus. La FDA a confirmé la voie réglementaire comme une NDA 505(b)(2) et a fourni des retours CMC sur les plans de lots d'enregistrement, la validation du procédé de fabrication, les spécifications du produit, les tests de stabilité et les études planifiées de manipulation/extraction in vitro de Catégorie 1. Nutriband intègre les directives de la FDA alors qu'il progresse vers une présentation IND pour soutenir une étude clinique sur le Potentiel d'Abus Humain (HAP). L'entreprise s'associe à Kindeva et estime un potentiel de ventes américaines peak entre $80M–$200M. Nutriband détient des brevets dans 46 pays.
Nutriband (NASDAQ:NTRB) erhielt Abschlussprotokolle von dem virtuellen persönlichen Treffen am 18. September 2025 mit der US-amerikanischen FDA bezüglich seines führenden Produkts AVERSA™ FENTANYL, eines fentanyl-transdermalen Systems mit Missbrauchsabschreckung. Die FDA bestätigte den regulatorischen Weg als 505(b)(2) NDA und gab CMC-Feedback zu Registrierungsbatch-Plänen, Validierung des Herstellungsprozesses, Produktspezifikationen, Stabilitätstests und geplanten Kategorie-1-In-vitro-Manipulations-/Extraktionsstudien. Nutriband berücksichtigt die FDA-Richtlinien, während es sich einer IND-Einreichung nähert, um eine klinische Studie zum Human Abuse Potential (HAP) zu unterstützen. Das Unternehmen arbeitet mit Kindeva zusammen und nennt ein Peak-US-Verkaufspotenzial von $80M–$200M. Nutriband hält Patente in 46 Ländern.
Nutriband (NASDAQ:NTRB) تلقّت محاضر الاجتماع النهائية من اجتماع افتراضي وجهًا لوجه بتاريخ 18 سبتمبر 2025 مع إدارة الغذاء والدواء الأمريكية (FDA) بشأن منتجها الرائد AVERSA™ FENTANYL، وهو نظام فنتانيل جلدي مضاد لسوء الاستخدام. أكّدت FDA المسار التنظيمي كــ NDA 505(b)(2) وأتاحت ملاحظات CMC حول خطط دفعات التسجيل، والتحقق من عملية التصنيع، ومزايا المنتج، واختبارات الثبات، والدراسات المخطط لها من النوع في-الأن vitro من الفئة 1 لتلافي التلاعب/الاستخراج. تقيم Nutriband إدراج FDA كمرجع أثناء تقدمها نحو تقديم IND لدعم دراسة قدرة الإيذاء البشرية (HAP) السريرية. تتشارك الشركة شراكة مع Kindeva وتذكر قدرة مبيعات ذروتها في الولايات المتحدة قدرها $80M–$200M. تمتلك Nutriband براءات اختراع في 46 دولة.
Nutriband (NASDAQ:NTRB) 收到与美国 FDA 于 2025 年 9 月 18 日进行的面对面虚拟会谈的最终会议纪要，涉及其主导产品 AVERSA™ FENTANYL，这是一种具有抑制滥用功能的芬太尼经皮系统。FDA 确认监管路径为 505(b)(2) NDA，并就注册批次计划、制造工艺验证、产品规格、稳定性测试以及计划中的第 1 类体外操作/提取研究提供了 CMC 反馈。Nutriband 正在将 FDA 指导意见融入其中，并向着支持人类滥用潜力（HAP）临床研究的 IND 申请迈进。公司与 Kindeva 合作，并引用美国市场的峰值销售潜力为 $80M–$200M。Nutriband 拥有 46 个国家的专利。
- FDA confirmed 505(b)(2) regulatory pathway
- Received final meeting minutes and actionable CMC feedback
- Advancing toward an IND filing for a HAP clinical study
- Partnership with Kindeva using an FDA-approved fentanyl patch
- Patent protection issued in 46 countries
- Projected peak annual US sales of $80M–$200M
- No abuse-deterrent fentanyl patch approved in the U.S. or globally to date
- Approval requires an IND and HAP clinical study before NDA submission
- FDA requested Category 1 in vitro manipulation/extraction studies and manufacturing validation
Insights
FDA confirmed a 505(b)(2) pathway and gave CMC and abuse‑deterrence feedback; IND for a HAP study is next.
Nutriband secured written minutes from the
The key dependencies are execution of the IND filing supporting a Human Abuse Potential study and completion of the laboratory and stability programs to meet the FDA’s CMC expectations. Risks remain until the IND and HAP study proceed and the NDA submission meets FDA requirements; no approvals or clinical results are reported yet. Watch for an IND filing date and the design/acceptance of the HAP study within the next regulatory milestones.
Product positioning and IP could support first‑to‑market abuse‑deterrent fentanyl patch, but commercial value is provisional.
AVERSA™ FENTANYL combines Nutriband’s abuse‑deterrent technology with an existing approved fentanyl patch via a partnership with Kindeva, and the company cites peak annual US sales potential of
Commercial outcomes depend on successful clinical and regulatory steps described by the FDA minutes and on market uptake if approved. Important near‑term items to monitor are the IND filing for the HAP study, the FDA’s acceptance of proposed Category 1 in vitro study data, and any formal agreement on pivotal study design and timelines.
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) through commercialization.
Nutriband received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential (HAP) clinical study for the product.
ORLANDO, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received final meeting minutes from its recent virtual face-to-face meeting held on September 18, 2025 with the United States Food and Drug Administration (US FDA) for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). The meeting was held as a videoconference with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER). The proposed indication is management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate.
The purpose of the meeting was 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).
The main outcomes of the meeting were:
- The FDA confirmed that the regulatory pathway for the product is a 505(b)(2) NDA and provided guidance on the relied upon reference listed drug and bridging strategy.
- FDA provided expectations and constructive feedback on the registration batch plan and manufacturing process validation strategy for NDA submission.
- FDA discussed various considerations and advice for the finalization of the product specifications and stability testing plans for the clinical and commercial products.
- FDA provided feedback on the planned laboratory-based in vitro manipulation and extraction studies (Category 1) to be conducted to fully characterize the product’s abuse-deterrent properties, including the degree of effort required by an abuser to bypass or defeat those properties.
In addition, the Division acknowledged that fentanyl patch abuse, misuse and accidental exposure is an important issue to address and offered their support and guidance during the development program through additional meetings as needed. In the past, the FDA has put out several warnings1,2 on the risks of fentanyl patch accidental exposure, particularly in children, but to date there have not been any abuse deterrent fentanyl patches approved in the U.S, or in any other country to our knowledge. Nutriband’s abuse deterrent fentanyl patch has the potential to be the first abuse deterrent patch approved worldwide.
“We are thankful for the opportunity to discuss the CMC aspects of our abuse deterrent fentanyl patch with the Agency. We are excited to incorporate the advice and constructive feedback that we received from the FDA into our development program as we move towards an IND filing in support of a Human Abuse Potential clinical study,” said Alan Smith, Ph.D., Chief Operating Officer of Nutriband, Inc. and President of 4P Therapeutics subsidiary of Nutriband.
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 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 FDA Consumer Update: Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children. (2024) https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children
2 FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death (2013). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requiring-color-changes-duragesic-fentanyl-pain-patches-aid-safety
3 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
What did Nutriband announce about its FDA meeting for AVERSA™ FENTANYL (NTRB) on Oct 28, 2025?
Does the FDA pathway confirmed for AVERSA™ FENTANYL (NTRB) allow reliance on a reference fentanyl product?
What near-term regulatory steps did Nutriband describe for AVERSA™ FENTANYL (NTRB)?
What commercial potential did Nutriband cite for AVERSA™ FENTANYL (NTRB)?
Who is Nutriband partnering with to develop AVERSA™ FENTANYL (NTRB)?
