Nutriband Advances Abuse-Deterrent Fentanyl Patch Toward FDA Submission Following Regulatory Feedback

Nutriband Inc. has received final meeting minutes from its September 18, 2025, virtual meeting with the U.S. Food and Drug Administration regarding the development pathway for AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal system. The regulatory feedback represents a crucial milestone for the company's lead product candidate and the broader effort to combat prescription opioid abuse.

The FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine confirmed the regulatory pathway as a 505(b)(2) New Drug Application, providing clear guidance on the reference listed drug and bridging strategy. This regulatory clarity is essential for streamlining the development process and potentially accelerating the product's path to market. The 505(b)(2) pathway allows companies to rely on existing data for approved drugs while introducing new features, in this case, abuse-deterrent technology.

Beyond confirming the regulatory framework, the FDA offered specific feedback on manufacturing validation, product specifications, and stability testing requirements. These manufacturing guidelines ensure that the product can be consistently produced to meet quality standards, a critical consideration for any pharmaceutical product but particularly important for controlled substances with abuse potential. The agency also outlined expectations for in vitro manipulation and extraction studies needed to characterize AVERSA's abuse-deterrent properties for potential NDA submission.

The development of abuse-deterrent formulations represents a significant public health priority as the opioid crisis continues to affect communities nationwide. Fentanyl patches have been subject to abuse through methods such as extraction of the active ingredient for injection or oral misuse. AVERSA technology aims to prevent these abuse patterns by incorporating features that resist manipulation and extraction. According to company information available at https://www.nutriband.com, the AVERSA technology can be incorporated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

This regulatory advancement comes at a critical time when healthcare providers and regulators are seeking balanced approaches to pain management that minimize abuse risks. The successful development of abuse-deterrent formulations could provide physicians with additional tools to safely manage severe chronic pain while reducing the potential for diversion and misuse. The company's progress is documented in its newsroom at https://ibn.fm/NTRB, though investors should note that any material contained in or derived from the company's websites is not part of the official press release.

The FDA's detailed feedback provides Nutriband with a clear roadmap for completing the necessary studies and documentation required for NDA submission. This regulatory milestone represents not just progress for a single company but reflects the ongoing collaboration between pharmaceutical developers and regulatory agencies to address complex public health challenges through technological innovation.