Nutriband's Abuse-Deterrent Patch Gains FDA Traction, Eyes $80M Market

NEW YORK, NY – October 28, 2025

FDA Greenlights Key Milestone for AVERSA™ FENTANYL

Nutriband Inc. announced today a significant regulatory step forward for its AVERSA™ FENTANYL transdermal patch, designed to deter opioid abuse. The company successfully completed a meeting with the Food and Drug Administration (FDA) regarding its Chemistry, Manufacturing, and Controls (CMC) plans, receiving constructive feedback and confirmation of the 505(b)(2) regulatory pathway. This positive development paves the way for Nutriband to submit an Investigational New Drug (IND) application for a Human Abuse Potential (HAP) clinical study.

This progress arrives against a backdrop of escalating opioid misuse and accidental exposure, a public health crisis demanding innovative solutions. While the market for pain management remains substantial, concerns over addiction and abuse are driving demand for safer delivery systems. Nutriband's AVERSA™ technology aims to address these concerns by incorporating aversive agents into the patch, discouraging oral abuse and accidental ingestion.

The Technology Behind Abuse Deterrence

The AVERSA™ FENTANYL patch distinguishes itself from traditional fentanyl transdermal systems through its unique abuse-deterrent mechanism. The technology utilizes a taste aversion component designed to discourage individuals from chewing or otherwise manipulating the patch to extract and consume the opioid. This approach targets a common method of abuse for transdermal fentanyl, where individuals attempt to bypass the extended-release mechanism by dissolving and injecting or ingesting the drug.

“The current opioid landscape necessitates a multi-faceted approach to address misuse and accidental exposure,” says one industry analyst. “Technologies like AVERSA™ represent a proactive step towards mitigating these risks, particularly for vulnerable populations.”

Nutriband has secured a robust intellectual property portfolio protecting the AVERSA™ technology, with patents issued in 46 countries. This global coverage strengthens the company's position and provides a competitive advantage in the emerging market for abuse-deterrent opioids. Recent patent allowances and applications demonstrate Nutriband’s commitment to continued innovation.

Navigating the Competitive Landscape and Market Potential

While several pharmaceutical companies are actively developing abuse-deterrent formulations, Nutriband’s approach appears to be uniquely positioned in the transdermal patch segment. Currently, there are no other abuse-deterrent fentanyl transdermal patches on the market. The company estimates the peak US market for AVERSA™ FENTANYL could reach $80 to $200 million, based on a market analysis report by Health Advances.

However, entering the market won't be without challenges. “The opioid market is highly competitive, and regulatory hurdles can be significant,” notes one pharmaceutical executive. “Nutriband will need to demonstrate both the efficacy and safety of its technology, as well as its ability to scale manufacturing and navigate the complex reimbursement landscape.”

Nutriband is partnering with Kindeva Drug Delivery, a global CDMO specializing in transdermal drug delivery, to support the development and manufacturing of AVERSA™ FENTANYL. Kindeva’s experience and manufacturing capabilities will be crucial in scaling production and ensuring consistent product quality. Kindeva’s recent expansion of manufacturing capacity, with projections exceeding 100 million units annually by 2025, suggests the company is prepared to meet potential demand.

The 505(b)(2) Pathway and Future Clinical Trials

The FDA's confirmation of the 505(b)(2) regulatory pathway is a significant win for Nutriband. This pathway allows the company to leverage existing data on approved fentanyl products, potentially streamlining the approval process and reducing development costs. By relying on previously established safety and efficacy data, Nutriband can focus on demonstrating the abuse-deterrent properties of its technology.

The next step for Nutriband is to submit an IND application for the HAP clinical study. This study will evaluate the potential for AVERSA™ FENTANYL to deter abuse compared to traditional fentanyl patches. If the study is successful, Nutriband plans to submit a New Drug Application (NDA) to the FDA seeking approval to market the product.

“The HAP study is critical,” explains a regulatory consultant. “It will provide the FDA with the evidence needed to assess the abuse-deterrent properties of the patch and determine whether it warrants a label claim. A positive outcome could significantly enhance the product’s commercial potential.”

The company expects to begin the clinical trials in early 2026. This could be the beginning of an important shift in how opioids are administered to patients, while reducing the risk of abuse and accidental overdose.