Curated News
By: NewsRamp Editorial Staff
October 28, 2025
Nutriband Advances Abuse-Deterrent Fentanyl Patch with FDA Guidance
TLDR
- Nutriband's FDA pathway confirmation for AVERSA FENTANYL positions the company ahead in the abuse-deterrent pharmaceutical market with a clear regulatory advantage.
- The FDA confirmed Nutriband's 505(b)(2) NDA pathway for AVERSA FENTANYL, providing guidance on manufacturing validation, stability testing, and abuse-deterrent characterization studies.
- Nutriband's abuse-deterrent fentanyl patch technology helps prevent drug misuse and accidental exposure, making pain management safer for patients and communities.
- Nutriband's AVERSA technology can be incorporated into any transdermal patch to prevent abuse of medications with high addiction potential.
Impact - Why it Matters
This development represents a critical advancement in addressing the ongoing opioid crisis by introducing technology that could significantly reduce prescription drug abuse. Fentanyl patches have been particularly vulnerable to misuse, with users sometimes extracting the potent opioid for unintended use, leading to overdoses and fatalities. Nutriband's AVERSA technology could transform how powerful pain medications are delivered, potentially saving lives and reducing healthcare costs associated with opioid abuse. For patients requiring strong pain management, this innovation offers the promise of effective relief with enhanced safety features. The FDA's engagement signals recognition of the urgent need for abuse-deterrent formulations, potentially setting new standards for opioid prescribing practices and patient protection.
Summary
Nutriband Inc. (NASDAQ: NTRB), a pioneering developer of prescription transdermal pharmaceutical products, has achieved a significant regulatory milestone with the U.S. Food and Drug Administration regarding its lead product, AVERSA™ FENTANYL. The company received final meeting minutes from its September 18, 2025, virtual meeting with the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine, confirming the regulatory pathway as a 505(b)(2) New Drug Application. This crucial development provides clear guidance on the reference listed drug and bridging strategy, while also offering valuable feedback on manufacturing validation, product specifications, and stability testing requirements. The FDA's comprehensive input represents a major step forward in Nutriband's journey toward potential NDA submission for this innovative abuse-deterrent transdermal system.
The AVERSA™ technology represents a groundbreaking approach to addressing the opioid crisis by incorporating abuse-deterrent properties directly into transdermal patches. This innovative technology can be integrated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. The FDA specifically outlined expectations for in vitro manipulation and extraction studies to characterize AVERSA's abuse-deterrent properties, underscoring the importance of this technology in the broader context of opioid safety. For investors and stakeholders following Nutriband's progress, the company maintains an active newsroom at https://ibn.fm/NTRB, providing regular updates on this promising development in pharmaceutical innovation.
This regulatory advancement positions Nutriband at the forefront of abuse-deterrent pharmaceutical technology, with potential implications for the entire transdermal drug delivery market. The company's website at www.nutriband.com offers additional information about their comprehensive portfolio of transdermal pharmaceutical products. The successful FDA meeting represents not just a corporate achievement but a meaningful step toward addressing one of healthcare's most pressing challenges. As the pharmaceutical industry continues to seek solutions for safer pain management, Nutriband's AVERSA technology demonstrates how innovative approaches can potentially transform patient safety while maintaining therapeutic efficacy in pain treatment protocols.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Nutriband Advances Abuse-Deterrent Fentanyl Patch with FDA Guidance
