Nutriband Secures FDA Meeting for Abuse-Deterrent Fentanyl Patch Development

Nutriband Inc. (NASDAQ: NTRB) has achieved a critical regulatory milestone with FDA approval for a Type C meeting concerning its AVERSA™ abuse-deterrent technology for fentanyl transdermal patches. The scheduled September 18 meeting with the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine will focus on comprehensive Chemistry, Manufacturing, and Controls plans that span the entire development and commercialization timeline for the product.

This regulatory engagement addresses the complete development pathway from Investigational New Drug submission through 505(b)(2) New Drug Application approval. The 505(b)(2) regulatory pathway enables Nutriband to leverage existing fentanyl safety data while concentrating regulatory review specifically on the novel abuse-deterrent components of their technology. This approach potentially accelerates the development process while maintaining rigorous safety standards.

The AVERSA™ technology represents a significant advancement in transdermal pharmaceutical delivery, designed to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. This technology can be incorporated into any transdermal patch, offering broad applications beyond fentanyl for various medications with abuse potential. The FDA's engagement signals recognition of the product's potential to address critical unmet medical needs in the ongoing opioid crisis.

For additional information about Nutriband Inc., visit https://www.Nutriband.com. The latest news and updates relating to NTRB are available in the company's newsroom at https://ibn.fm/NTRB.