Nutriband announces meeting completed with U.S. FDA for AVERSA FENTANYL

Nutriband (NTRB) announced that it has received final meeting minutes from its recent virtual face-to-face meeting held on September 18, 2025 with the United States Food and Drug Administration, FDA, for its lead product, AVERSA FENTANYL. The meeting was held as a videoconference with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine, DAAP, in the Office of Neuroscience, ON, Center for Drug Evaluation and Research, CDER. The main outcomes of the meeting were: The FDA confirmed that the regulatory pathway for the product is a 505(b)(2) NDA and provided guidance on the relied upon reference listed drug and bridging strategy. FDA provided expectations and constructive feedback on the registration batch plan and manufacturing process validation strategy for NDA submission. FDA discussed various considerations and advice for the finalization of the product specifications and stability testing plans for the clinical and commercial products. FDA provided feedback on the planned laboratory-based in vitro manipulation and extraction studies to be conducted to fully characterize the product’s abuse-deterrent properties, including the degree of effort required by an abuser to bypass or defeat those properties.