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.
