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 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 - 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].