FAQ: Nutriband's FDA Meeting Feedback for AVERSA™ Fentanyl Abuse-Deterrent Patch

What is the main announcement from Nutriband Inc.?

Nutriband has received final meeting minutes from its September 18, 2025, virtual meeting with the FDA regarding its lead product, AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal system.

What regulatory pathway was confirmed for AVERSA™ Fentanyl?

The FDA confirmed the regulatory pathway as a 505(b)(2) New Drug Application (NDA) for AVERSA™ Fentanyl.

What specific feedback did the FDA provide during the meeting?

The FDA provided guidance on the reference listed drug and bridging strategy, along with feedback on manufacturing validation, product specifications, stability testing, and expectations for in vitro manipulation and extraction studies to characterize AVERSA’s abuse-deterrent properties.

What is AVERSA™ technology and how does it work?

AVERSA™ is an abuse-deterrent technology that can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

What is Nutriband Inc.’s primary business focus?

Nutriband is primarily engaged in the development of a portfolio of transdermal pharmaceutical products, with AVERSA™ Fentanyl as its lead product under development.

When did the FDA meeting take place?

The virtual meeting with the FDA occurred on September 18, 2025.

Which FDA division was involved in the meeting?

The meeting was with the FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine.

Where can investors find more information about Nutriband?

The latest news and updates relating to NTRB are available in the company’s newsroom at https://ibn.fm/NTRB.

What is the significance of the FDA feedback for AVERSA™ Fentanyl?

The FDA feedback advances AVERSA™ Fentanyl toward potential NDA submission by confirming the regulatory pathway and providing specific guidance on development requirements and abuse-deterrent characterization studies.