Nutriband Receives FDA Feedback Advancing Abuse-Deterrent Fentanyl Patch Toward Regulatory Submission

Nutriband Inc. has received final meeting minutes from its September 18, 2025, virtual meeting with the U.S. Food and Drug Administration regarding its lead product, AVERSA™ 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. This regulatory clarity represents a critical milestone for the company's development program and positions the product for potential submission to address the ongoing opioid crisis.

The FDA feedback included specific direction on manufacturing validation, product specifications, and stability testing requirements that will guide Nutriband's preparation for regulatory submission. Additionally, the agency provided expectations for in vitro manipulation and extraction studies needed to characterize AVERSA's abuse-deterrent properties. These studies are essential for demonstrating the technology's effectiveness in preventing misuse and abuse of the potent opioid medication. The company's website at https://www.nutriband.com provides additional corporate information, though the press release notes that website content is not formally part of the announcement.

The advancement of AVERSA™ Fentanyl through the regulatory process holds significant implications for pain management and addiction prevention. Fentanyl transdermal patches have been subject to abuse through methods such as chewing, extraction, or smoking the medication, contributing to the opioid epidemic. The development of abuse-deterrent formulations represents an important public health initiative to balance legitimate pain treatment needs with safety considerations. The technology's potential application extends beyond fentanyl, as AVERSA™ technology can be incorporated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

Investors can access the latest news and updates relating to NTRB through the company's newsroom at https://ibn.fm/NTRB, which provides ongoing coverage of the company's development progress. The regulatory feedback received positions Nutriband to advance its development program with clearer understanding of FDA requirements and expectations. This progress comes at a time when the healthcare community continues to seek solutions that address both pain management needs and the risks associated with opioid medications. The successful development of abuse-deterrent technologies could represent an important step forward in balancing these competing public health priorities while providing new options for patients requiring potent pain management solutions.