Nutriband receives FDA feedback on abuse deterrent fentanyl patch

Nutriband Inc. (NASDAQ: NTRB) announced it received final meeting minutes from a September 18 virtual meeting with the U.S. Food and Drug Administration regarding its AVERSA fentanyl abuse deterrent transdermal system.

The meeting with the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine focused on Chemistry, Manufacturing, and Controls plans for the product from investigational new drug application submission through commercial approval.

The FDA confirmed the regulatory pathway as a 505(b)(2) New Drug Application and provided guidance on the reference drug and bridging strategy. The agency also gave feedback on registration batch plans, manufacturing process validation, product specifications, and stability testing for clinical and commercial products.

The FDA provided input on planned laboratory studies to characterize the product's abuse-deterrent properties and the effort required to bypass those properties. The agency acknowledged that fentanyl patch abuse and accidental exposure represent important issues and offered ongoing support during development.

"We are excited to incorporate the advice and constructive feedback that we received from the FDA into our development program as we move towards an IND filing in support of a Human Abuse Potential clinical study," said Alan Smith, the company's chief operating officer.

Nutriband is partnering with Kindeva to develop the product, which combines Nutriband's AVERSA abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. The company stated this could potentially be the first abuse deterrent fentanyl patch approved worldwide.

The proposed indication covers management of pain in opioid-tolerant patients requiring daily, around-the-clock, long-term opioid treatment where alternative options are inadequate. The technology is protected by patents in 46 countries.

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