Prescription pharmaceutical transdermal fentanyl is a valuable treatment for management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment for which alternate treatment options are inadequate. Illicit fentanyl and its core precursor chemicals have been designated as weapons of mass destruction to enable the US government to combat the manufacture and distribution by cartels and foreign networks that have flooded the US with illegal fentanyl. Nut ...

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following a constructive meeting with the US FDA to discuss its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][4][6] Group 1: FDA Meeting Outcomes - The FDA provided feedback on the CMC plans from IND submission to 505(b)(2) New Drug Application (NDA) approval [3][6] - The FDA acknowledged the importance of addressing fentanyl patch abuse and offered ongoing support during the development program [4][5] - Nutriband's product has the potential to be the first abuse-deterrent fentanyl patch approved globally, addressing a significant unmet medical need [4][10] Group 2: Product Development and Market Potential - AVERSA™ FENTANYL is designed for pain management in opioid-tolerant patients requiring long-term opioid treatment [2][3] - The product is projected to achieve peak annual US sales between $80 million to $200 million, with plans to expand into major global markets [10] - Nutriband's AVERSA™ technology incorporates aversive agents to enhance the safety profile of transdermal drugs susceptible to abuse [9][12] Group 3: Intellectual Property and Partnerships - The AVERSA™ technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries [11][12] - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, combining its technology with Kindeva's FDA-approved fentanyl patch [8][9]

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following positive feedback from the US FDA regarding its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][3][4]. Product Development - The FDA meeting on September 18, 2025, provided critical feedback for the development program, focusing on the CMC plans from IND submission to 505(b)(2) New Drug Application (NDA) approval [2][3]. - Nutriband is incorporating FDA feedback into its development program, which is essential for the upcoming IND filing [4]. - The FDA acknowledged the significant issue of fentanyl patch abuse and offered ongoing support and guidance throughout the development process [3]. Market Potential - AVERSA™ FENTANYL has the potential to achieve peak annual US sales between $80 million to $200 million, with plans to address unmet medical needs for pain management globally [7]. - The product aims to be the first abuse-deterrent fentanyl patch approved worldwide, addressing a critical gap in the market [3][6]. Technology and Partnerships - Nutriband's AVERSA™ technology incorporates aversive agents into transdermal patches to mitigate abuse, misuse, and accidental exposure, enhancing the safety profile of drugs like fentanyl [6][10]. - The company is collaborating with Kindeva to develop AVERSA™ FENTANYL, combining its technology with Kindeva's FDA-approved fentanyl patch [5]. Regulatory Pathway - The FDA confirmed that the regulatory pathway for AVERSA™ FENTANYL is a 505(b)(2) NDA, providing guidance on the reference listed drug and bridging strategy [7]. - The FDA also discussed expectations for the registration batch plan and manufacturing process validation strategy for NDA submission [7].

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following positive feedback from the US FDA regarding its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][3][4]. Company Developments - Nutriband held a virtual meeting with the FDA on September 18, 2025, to discuss the CMC aspects of AVERSA™ FENTANYL, which is intended for pain management in opioid-tolerant patients [2][3]. - The FDA provided constructive feedback on the registration batch plan, manufacturing process validation strategy, and product specifications for the 505(b)(2) New Drug Application (NDA) submission [7][3]. - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, integrating its abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [5][11]. Market Potential - AVERSA™ FENTANYL has the potential to achieve peak annual sales in the US ranging from $80 million to $200 million, addressing a significant unmet medical need for effective pain management [7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, enhancing its market position [8][10]. Product Features - The AVERSA™ abuse-deterrent technology aims to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, particularly opioids like fentanyl [6][10]. - The FDA acknowledged the importance of addressing fentanyl patch abuse and offered ongoing support and guidance throughout the development process [3][4].

Core Points - Nutriband Inc. has announced the return of founder Gareth Sheridan as CEO, effective immediately, after Serguei Melnik temporarily took over the role from August 10 to October 27, 2025 [1] - The company is focused on advancing its lead product, AVERSA Fentanyl, towards a target NDA filing in 2026 [1] Group 1: Product Overview - AVERSA Fentanyl is positioned to be the world's first abuse-deterrent opioid patch, aimed at preventing abuse and reducing accidental exposure risks associated with transdermal fentanyl patches [2] - The product has the potential to achieve peak annual sales in the US ranging from $80 million to $200 million, with plans to expand into major global medical markets [2] Group 2: Technology and Intellectual Property - The AVERSA abuse-deterrent technology is protected by a comprehensive international intellectual property portfolio, with patents issued in 46 countries, including the US, Europe, Japan, and China [3] - This technology incorporates aversive agents into transdermal patches to mitigate the risks of abuse, misuse, and accidental exposure while ensuring accessibility for patients in need [3][4] Group 3: Company Background - Nutriband Inc. specializes in developing a range of transdermal pharmaceutical products, with AVERSA Fentanyl being the lead product under development [4] - The AVERSA technology can be integrated into any transdermal patch to enhance safety and prevent misuse of drugs with abuse potential [4]

Core Insights - Nutriband has initiated the development of a worldwide brand name for its lead product, an abuse-deterrent fentanyl transdermal system, in partnership with Brand Institute, Inc [1][10] - The AVERSA™ FENTANYL product aims to be the first abuse-deterrent opioid patch, designed to prevent misuse and accidental exposure to fentanyl [2][6] Company Overview - Nutriband is focused on developing transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [8] - The AVERSA™ technology incorporates aversive agents into transdermal patches to mitigate the risks of abuse and accidental exposure [6][7] Brand Development - Developing a proprietary brand name is crucial for distinguishing the product from similar-sounding or looking drug names, which can prevent medication errors [3] - Brand Institute holds a significant market share, with a 75% approval rate for drug names globally, including 87% of FDA-approved names in 2024 [4][10] Regulatory Support - Drug Safety Institute, a subsidiary of Brand Institute, will provide regulatory services for the project, staffed by former officials from major health agencies [5][10] - The expertise of Drug Safety Institute includes co-authoring naming guidance documents, ensuring safety and preventing medication errors [5][10]

Core Viewpoint - Nutriband Inc. has filed a provisional patent application to enhance its AVERSA™ transdermal abuse deterrent technology aimed at preventing the misuse of opioids and stimulants [1][2]. Group 1: Patent Application and Technology - The provisional patent application focuses on improved aversive formulations and coating methods to strengthen the abuse deterrent properties of the AVERSA™ technology [2]. - If converted to a non-provisional patent, it could extend patent protection for products utilizing AVERSA™ for 20 years from the non-provisional filing date [2]. - The AVERSA™ technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries, including the U.S., Europe, Japan, and China [3]. Group 2: Technology Applications and Benefits - AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, such as opioids and stimulants [4][5]. - This technology aims to improve the safety profile of transdermal drugs while ensuring accessibility for patients who genuinely need them [4][5]. Group 3: Company Overview - Nutriband Inc. is primarily focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [6].

Core Insights - Nutriband Inc. reported strong financial results for the six months ended July 31, 2025, with a cash position of $6.9 million and total assets valued at $10.17 million, supporting the development of its lead product, AVERSA™ Fentanyl [1][5] - The company achieved record revenue of $1,289,884 from its kinesiology tape contract manufacturing services, reflecting a year-over-year increase of 50.87% [2] - AVERSA Fentanyl is on track for development, with the NDA relying on a single phase 1 Human Abuse Potential study, eliminating the need for Phase 2 or Phase 3 trials before submission [3] Product Development - AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch globally, with estimated peak annual sales potential ranging from $80 million to $200 million [4] - The second application, AVERSA Buprenorphine, is projected to reach peak annual sales of up to $130 million [4] - The company emphasizes its AVERSA™ technology, designed to prevent abuse, misuse, and accidental exposure of drugs with abuse potential [6] Financial Position - As of July 31, 2025, Nutriband's stockholders' equity amounted to $8.5 million, indicating a solid financial foundation for ongoing development and commercialization efforts [5]

Core Viewpoint - Nutriband Inc. CEO Gareth Sheridan will temporarily step aside to participate in the Irish Presidential Election, with Chairman Serguei Melnik taking over as interim CEO during this period [1][2][3] Company Leadership Transition - Gareth Sheridan will step down for three months, with the nomination hearings and election occurring in September and October [1] - Serguei Melnik, co-founder and Chairman, will assume CEO responsibilities and guide the company towards its NDA filing target in 2026 [2] Strategic Focus - Melnik, with over 20 years of experience in capital markets, will continue to execute the company's strategic development and focus on enhancing shareholder value [2] - Sheridan emphasized the strength of the company's team as its core asset and expressed confidence in meeting planned targets during his absence [3] Product Development - Nutriband's lead product, AVERSA Fentanyl, has received FDA approval for a meeting request, positioning it as a potential first-of-its-kind abuse-deterrent opioid patch [4] - AVERSA Fentanyl is projected to achieve peak annual US sales between $80 million and $200 million, with plans to expand into major global markets [4] Intellectual Property - The AVERSA technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the US, Europe, and China [5] Company Overview - Nutriband Inc. focuses on developing transdermal pharmaceutical products, with AVERSA technology designed to prevent the abuse and accidental exposure of drugs with abuse potential [6]

Core Viewpoint - The FDA has granted Nutriband a Type C Meeting to discuss the Chemistry, Manufacturing, and Controls plans for its AVERSA™ FENTANYL product, which aims to provide an abuse-deterrent transdermal system for fentanyl [1][2]. Group 1: Product Development - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, integrating Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [1][2]. - The AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, misuse, and accidental exposure of drugs with abuse potential, particularly opioids [3][6]. Group 2: Market Potential - AVERSA FENTANYL could be the first abuse-deterrent opioid patch, with potential peak annual sales in the U.S. estimated between $80 million and $200 million [4]. - The company aims to address the global unmet medical need for effective pain management by making AVERSA FENTANYL available in major medical markets worldwide [4]. Group 3: Intellectual Property - The AVERSA™ abuse-deterrent technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the U.S., Europe, Japan, and China [5][6]. Group 4: Company Overview - Nutriband is focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being the abuse-deterrent fentanyl patch [7].