FAQ: Nutriband Inc.'s AVERSA™ Technology and FDA Engagement

What is Nutriband Inc. and what does it develop?

Nutriband Inc. (NASDAQ: NTRB) is a transdermal pharmaceutical developer focused on creating abuse-deterrent technologies. Its lead product is an abuse-deterrent fentanyl patch incorporating AVERSA™ technology.

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 abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. It specifically targets fentanyl in Nutriband’s lead product.

What FDA milestone has Nutriband achieved for AVERSA™ Fentanyl?

Nutriband has secured FDA approval for a Type C Meeting scheduled for September 18th with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine to discuss Chemistry, Manufacturing, and Controls (CMC) plans for AVERSA™ Fentanyl.

Why is this FDA meeting significant for Nutriband?

This meeting represents agency recognition of the product’s potential to address critical unmet medical needs and addresses the complete development arc from IND submission through 505(b)(2) NDA approval for commercialization.

What is the 505(b)(2) regulatory pathway mentioned?

The 505(b)(2) pathway allows Nutriband to leverage existing fentanyl safety data while focusing regulatory review specifically on the novel abuse-deterrent components of their AVERSA™ technology, streamlining the approval process.

When is the key FDA meeting taking place?

The FDA Type C Meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine is scheduled for September 18th to discuss CMC plans for AVERSA™ Fentanyl.

Where can I find more information about Nutriband Inc.?

More information about Nutriband is available at their website www.Nutriband.com and latest updates are in the company’s newsroom at https://ibn.fm/NTRB.

What are the potential benefits of AVERSA™ technology?

AVERSA™ technology prevents abuse, misuse, diversion, and accidental exposure of drugs with abuse potential, specifically addressing the opioid crisis by making fentanyl patches safer and more secure.

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