Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch

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].