Nutriband Provides Product Development Update for Its Lead Product Aversa Fentanyl
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ORLANDO, FL / ACCESSWIRE / June 20, 2024 / Nutriband Inc.("Company") (NASDAQ:NTRB)(NASDAQ:NTRBW) provides an update on its Aversa Fentanyl product development program to shareholders as it aims to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to NDA filing.
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As previously reported, the Company with its partner Kindeva Drug Delivery completed the feasibility agreement and entered into a commercial development and clinical supply agreement to manufacture product for the human abuse potential clinical study in support of a New Drug Application (NDA) to be submitted to FDA. The feasibility agreement was focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA? abuse deterrent transdermal technology.
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Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product which will incorporate Nutriband's AVERSA? abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system.
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Recently, Kindeva Drug Delivery completed the validation of the aversive agent cleaning analytical methods required to allow work with the aversive agents, denatonium benzoate and capsaicin, on the commercial manufacturing line.
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Once the final commercial product manufacturing process is completed, Nutriband intends to file an IND with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance.
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Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for its NDA. The IND will include the chemistry, manufacturing, and controls (CMC) information for the commercial product as well as the clinical study protocol for the human abuse potential study.
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No Phase 2 or phase 3 Clinical Trials are required prior to submitting for approval.
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AVERSA(TM) Fentanyl is estimated to have the potential to reach peak annual US sales of $80 million to $200 million, according to a market analysis report from Health Advances(1).
The pivotal laboratory assessment to be conducted is a series of in vitro manipulation and extraction studies designed to determine if the potentially abuse-deterrent properties of the product can be defeated or compromised based on physical and chemical manipulation of the product. Preliminary studies conducted to date have shown that the AVERSA technology is very difficult to defeat by various physical or chemical means.