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Nutriband Inc. Advances Toward FDA Approval for AVERSA(TM) Fentanyl Abuse-Deterrent Patch

By Advos

TL;DR

Nutriband's AVERSA Fentanyl patch, with FDA meeting set for 2025, offers a competitive edge by targeting $80M-$200M in U.S. sales with its abuse-deterrent technology.

Nutriband's AVERSA Fentanyl patch combines abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, aiming to prevent misuse while ensuring patient access through a detailed CMC review process.

The development of AVERSA Fentanyl by Nutriband aims to reduce opioid abuse and accidental exposure, contributing to a safer healthcare environment for patients globally.

Nutriband is pioneering the first abuse-deterrent opioid patch, AVERSA Fentanyl, protected by patents in 46 countries, marking a significant advancement in transdermal pharmaceutical technology.

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Nutriband Inc. Advances Toward FDA Approval for AVERSA(TM) Fentanyl Abuse-Deterrent Patch

Nutriband Inc. (NASDAQ: NTRB), a leader in the development of prescription transdermal pharmaceutical products, has announced a significant milestone in its quest to combat the opioid crisis. The U.S. Food and Drug Administration (FDA) has scheduled a Type C Meeting for September 18, 2025, to review the Chemistry, Manufacturing, and Controls (CMC) plans for its innovative AVERSA(TM) Fentanyl abuse-deterrent patch. This development marks a critical step forward in the company's efforts to address the rampant issues of abuse, diversion, misuse, and accidental exposure associated with fentanyl patches.

Developed in collaboration with Kindeva, AVERSA(TM) Fentanyl is designed to integrate Nutriband's proprietary abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. This partnership aims to deliver a product that not only mitigates the risks of opioid abuse but also ensures that patients suffering from severe pain have access to the medication they need. With patents protecting the technology in 46 countries, AVERSA(TM) Fentanyl is poised to become the world's first abuse-deterrent opioid patch, targeting a peak annual U.S. sales potential of $80 million to $200 million, with plans for global expansion.

The significance of this development cannot be overstated, given the ongoing opioid epidemic that has claimed thousands of lives annually. The AVERSA(TM) technology represents a promising solution to a public health crisis, offering a way to prevent the abuse of potent opioids like fentanyl without denying access to those who genuinely need them for pain management. For more information on Nutriband's innovative approach to tackling opioid abuse, visit https://www.nutriband.com.

As the FDA meeting date approaches, stakeholders from across the healthcare and pharmaceutical industries will be watching closely. The potential approval of AVERSA(TM) Fentanyl could herald a new era in pain management, one where the benefits of opioids can be harnessed without the accompanying risks of abuse and addiction. For the latest updates on Nutriband Inc. and its groundbreaking work, visit https://ibn.fm/NTRB.

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