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 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]