Nutriband Advances Aversa™ Fentanyl Patch Development

Nutriband Moves Forward with Aversa™ Fentanyl Patch

The FDA has granted a pivotal meeting for Nutriband's AVERSA™ FENTANYL, an innovative abuse-deterrent transdermal system aimed at combating opioid misuse.

Nutriband has joined forces with Kindeva to develop this unique product, leveraging Nutriband’s advanced AVERSA™ technology alongside a well-established fentanyl patch already approved by the FDA.

Recently, Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a frontrunner in the development of transdermal pharmaceutical solutions, confirmed the successful request for a Type C Meeting by the United States Food and Drug Administration (US FDA). This meeting is crucial as it aims to deliver important insights regarding the Chemistry, Manufacturing, and Controls (CMC) plans for the AVERSA™ FENTANYL patch which is set to transition from its Investigational New Drug Application (IND) to a 505(b)(2) New Drug Application (NDA) and eventual market introduction.

Scheduled as a virtual encounter, the meeting on September 18 will involve key representatives from the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP), part of the Office of Neuroscience (ON) within the Center for Drug Evaluation and Research (CDER).

This collaboration with Kindeva aims to merge Nutriband’s innovative AVERSA™ abuse-deterrent technology with Kindeva’s production capabilities to create a safe and effective fentanyl patch.

AVERSA™ technology integrates aversive agents into transdermal patches to deter potential abuse, diversion, and other risks associated with opioid medications. This technological advancement not only aims to enhance safety for patients but also ensures that those in genuine need of pain relief have access to these critical treatments.

The Aversa Fentanyl patch stands out as a potential game-changer, aiming to become the world’s first abuse-deterrent opioid patch. Its design is intended to significantly reduce the misuse and accidental exposure linked to transdermal fentanyl applications. The market for AVERSA FENTANYL could range between $80 million to $200 million annually in the US alone, reflecting the pressing medical demand for better pain management solutions.

Starting with the US market, Nutriband recognizes the global necessity for effective pain relief, making it a priority to expand AVERSA FENTANYL’s availability in major markets worldwide.

Protecting this cutting-edge technology, Nutriband holds a robust international portfolio of intellectual property, with patents granted across 46 countries. This includes key markets such as the United States, various nations in Europe, Japan, Korea, China, Russia, Canada, Mexico, and Australia.

Exploring AVERSA™ Abuse-Deterrent Transdermal Technology

The AVERSA™ abuse-deterrent transdermal technology serves to incorporate aversive compounds into opioid delivery systems, effectively protecting against misuse and ensuring product integrity. This cutting-edge method enhances the safety profile of transdermal drugs, especially those prone to abuse, like the one we're discussing. With the potential to improve access for patients who rely on these treatments, AVERSA™ reflects Nutriband’s commitment to innovation in pain management.

About Nutriband Inc.

Nutriband is dedicated to developing a diverse range of transdermal pharmaceutical products, with its lead offering being the abuse-deterrent fentanyl patch. The AVERSA™ technology is pivotal in preventing common risks such as abuse and accidental exposure linked to many medications.

For more information about Nutriband, the Company encourages interested parties to visit www.nutriband.com.

About Kindeva

Kindeva's mission is to create a better future for patients globally. They combine excellence in their facilities with comprehensive contract development and manufacturing services (CDMO). Their integrated capabilities excel in drug delivery solutions that include injectable and transdermal forms, meeting the evolving needs of healthcare.

Frequently Asked Questions

What is the AVERSA™ Fentanyl patch?

The AVERSA™ Fentanyl patch is an innovative transdermal system designed to deter misuse and improve safety for patients requiring opioid pain management.

How is Nutriband partnering with Kindeva?

Nutriband collaborates with Kindeva to integrate its AVERSA™ abuse-deterrent technology into an FDA-approved fentanyl patch to enhance patient safety.

What feedback is Nutriband seeking from the FDA?

The feedback pertains to Chemistry, Manufacturing, and Control plans for the AVERSA™ product, essential for its approval process.

What is the market potential for AVERSA FENTANYL?

The product could potentially capture annual US sales between $80 million to $200 million due to the significant need for effective pain management solutions.

Is the AVERSA™ technology protected?

Yes, Nutriband has a broad international intellectual property portfolio securing patents in 46 countries, safeguarding the AVERSA™ technology.

About The Author

Hello, I'm Thomas Cooper, a financial expert and writer passionate about helping people understand and navigate the financial world. Having a solid financial background and a lot of experience, my area of expertise is simplifying difficult financial ideas into useful, understandable guidance. My goal with my writings and blog entries is to provide you the information and resources you need to make wise financial choices.

I am thrilled to contribute my ideas and engage with a lively investor community at Investors Hangout, where I recently joined the team. My mission is to make finance interesting and approachable so you may take charge of your financial future. I appreciate you coming along on this path to success and financial knowledge.

Contact Thomas Cooper privately here. Or send an email with ATTN: Thomas Cooper as the subject to contact@investorshangout.com.

About Investors Hangout

Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/

The content of this article is based on factual, publicly available information and does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice, and the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. This article should not be considered advice to purchase, sell, or hold any securities or other investments. If any of the material provided here is inaccurate, please contact us for corrections.