FDA approves meeting request for Nutriband's fentanyl patch development

The Food and Drug Administration has granted Nutriband Inc. (NASDAQ: NTRB) a Type C Meeting to discuss the Chemistry, Manufacturing, and Controls plans for its AVERSA Fentanyl abuse-deterrent transdermal system, according to a company statement.

The virtual meeting is scheduled for September 18 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine in the Office of Neuroscience, Center for Drug Evaluation and Research. The meeting will cover the product's development from Investigational New Drug Application submission through New Drug Application approval and commercialization.

Nutriband is developing the product in partnership with Kindeva, combining Nutriband's AVERSA abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. The technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.

The company's AVERSA technology is protected by patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. Nutriband cited a 2022 Health Advances market analysis report projecting potential peak annual US sales of $80 million to $200 million for the product.

The Orlando-based company focuses on developing transdermal pharmaceutical products, with the abuse-deterrent fentanyl patch as its lead product under development.

You May Also Be Interested In

• Mesoblast draws $50M from five-year facility to retire existing debt
• Goldman Sachs (GS) Reiterated at Market Perform by Citizens on Constructive Backdrop
• Ollin Biosciences raises $330M Series B to fund eye disease trials