NTRB - BioMedNewsBreaks - Nutriband Inc. (NASDAQ: NTRB) Receives FDA Meeting Feedback Advancing AVERSA(TM) Fentanyl Toward 505(b)(2) NDA Submission
2025-10-28 10:58:39 ET
Nutriband (NASDAQ: NTRB) , a developer of prescription transdermal pharmaceutical products, today announced it has received final meeting minutes from its Sept. 18, 2025, virtual meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product, AVERSA(TM) FENTANYL, an abuse-deterrent fentanyl transdermal system. The meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine confirmed the regulatory pathway as a 505(b)(2) New Drug Application and provided guidance on the reference listed drug and bridging strategy. The FDA also offered feedback on manufacturing validation, product specifications, and stability testing, along with expectations for in vitro manipulation and extraction studies to characterize AVERSA’s abuse-deterrent properties for potential NDA submission.
To view the full press release, visit https://ibn.fm/RAzqc
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA(TM) abuse-deterrent technology. AVERSA(TM) technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com . Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://ibn.fm/NTRB
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