REPEAT — 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]. 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].