FAQ: Nutriband's FDA Feedback for AVERSA™ Fentanyl Abuse-Deterrent Patch
Summary
Nutriband Inc. has received final FDA meeting minutes confirming the 505(b)(2) regulatory pathway for its AVERSA™ Fentanyl abuse-deterrent transdermal system. This feedback provides crucial guidance on manufacturing, testing, and abuse-deterrent characterization needed for potential NDA submission.
What is the main announcement from Nutriband Inc.?
Nutriband Inc. has received final meeting minutes from its September 18, 2025, virtual FDA meeting regarding AVERSA™ Fentanyl, confirming the 505(b)(2) New Drug Application regulatory pathway and providing guidance on manufacturing validation, product specifications, and abuse-deterrent characterization studies.
What is AVERSA™ Fentanyl and what makes it unique?
AVERSA™ Fentanyl is an abuse-deterrent fentanyl transdermal system that incorporates Nutriband’s AVERSA™ technology to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. It’s the company’s lead product under development.
Why is this FDA feedback significant for Nutriband?
This FDA feedback is significant because it confirms the regulatory pathway as a 505(b)(2) NDA and provides specific guidance on reference listed drugs, bridging strategy, manufacturing validation, and abuse-deterrent testing requirements, advancing the product toward potential submission.
What specific feedback did the FDA provide during the meeting?
The FDA provided feedback on manufacturing validation, product specifications, stability testing, and expectations for in vitro manipulation and extraction studies to characterize AVERSA’s abuse-deterrent properties for potential NDA submission.
When did the FDA meeting take place and what division was involved?
The virtual FDA meeting took place on September 18, 2025, with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine overseeing the regulatory review process.
What type of company is Nutriband Inc.?
Nutriband Inc. is a developer of prescription transdermal pharmaceutical products, primarily engaged in developing a portfolio of transdermal pharmaceutical products with a focus on abuse-deterrent technology.
Where can investors find more information about Nutriband?
Investors can find the latest news and updates relating to NTRB in the company’s newsroom at https://ibn.fm/NTRB and view the full press release at https://ibn.fm/RAzqc. The company’s website is www.nutriband.com.
What is the 505(b)(2) regulatory pathway mentioned in the announcement?
The 505(b)(2) New Drug Application is a regulatory pathway that allows companies to seek FDA approval for new drug products that contain active ingredients already approved by the FDA, potentially streamlining the approval process by relying on existing safety and efficacy data.
How does AVERSA™ technology work and what drugs can it be used with?
AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential, though the current focus is on the fentanyl transdermal system as the lead product.
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