Nutriband Advances AVERSA™ Fentanyl Abuse-Deterrent Patch Following FDA Regulatory Feedback

Nutriband Inc. has achieved a significant regulatory milestone for its lead pharmaceutical product, receiving final meeting minutes from its September 18, 2025, virtual meeting with the U.S. Food and Drug Administration regarding AVERSA™ Fentanyl. The company, which trades on NASDAQ under the symbol NTRB, develops prescription transdermal pharmaceutical products and is advancing an abuse-deterrent fentanyl transdermal system designed to combat opioid misuse.

The FDA meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine confirmed the regulatory pathway as a 505(b)(2) New Drug Application, providing crucial guidance on the reference listed drug and bridging strategy. This regulatory confirmation represents a critical step forward in the development process, potentially accelerating the path toward market approval for a technology that could significantly impact opioid abuse prevention.

The FDA provided comprehensive feedback covering multiple aspects of the product development process, including manufacturing validation requirements, product specifications, and stability testing protocols. Additionally, the agency outlined expectations for in vitro manipulation and extraction studies necessary to characterize AVERSA's abuse-deterrent properties for potential NDA submission. These studies are essential for demonstrating how the technology prevents misuse of the potent opioid medication.

AVERSA™ technology represents a novel approach to addressing the ongoing opioid crisis by incorporating abuse-deterrent properties directly into transdermal patch formulations. The technology can be incorporated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. This innovation comes at a critical time when opioid abuse remains a significant public health concern across the United States and globally.

The advancement of AVERSA™ Fentanyl through the regulatory process holds substantial implications for healthcare providers, patients, and public health officials. For chronic pain patients who require potent opioid medications, an abuse-deterrent formulation could provide necessary pain relief while reducing the risk of misuse and diversion. Healthcare providers may benefit from having additional tools to manage pain while addressing concerns about medication safety and potential abuse.

The regulatory progress also signals potential market opportunities in the pharmaceutical industry's ongoing efforts to develop safer opioid formulations. As regulatory agencies continue to prioritize abuse-deterrent technologies, successful development of products like AVERSA™ Fentanyl could establish new standards for opioid medication safety. The company maintains additional information through its corporate communications at https://www.nutriband.com.

This development occurs within the broader context of increased regulatory focus on opioid safety and abuse prevention. The FDA's detailed feedback and confirmation of the 505(b)(2) pathway suggest alignment between regulatory priorities and industry innovation in addressing public health challenges. The progress of AVERSA™ Fentanyl represents an important step toward potentially providing healthcare professionals with additional tools to balance effective pain management with enhanced safety measures against opioid misuse.