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].

Core Viewpoint - Nutriband has successfully completed the commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, in partnership with Kindeva, marking a significant milestone towards developing a commercially viable abuse-deterrent fentanyl patch [1][3]. Group 1: Product Development - Aversa™ Fentanyl combines Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, and is manufactured at Kindeva's advanced transdermal facility in the United States [2]. - The next steps include manufacturing clinical supplies and filing an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study [2]. Group 2: Market Potential - Aversa Fentanyl has the potential to be the first abuse-deterrent opioid patch on the market, aimed at deterring abuse and reducing accidental exposure risks, with projected peak annual US sales between $80 million to $200 million [5]. - The company plans to initially focus on the US market while also targeting global markets due to the widespread unmet medical need for effective pain management [5]. Group 3: Technology and Intellectual Property - Nutriband's AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent drug abuse, ensuring that these medications remain accessible to patients in need [4][7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including major markets such as the United States, Europe, and China [6][7].