Nutriband Provides Product Development Update for Its Lead Product Aversa Fentanyl
- 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. Nutriband is currently working with its partnerKindeva Drug Delivery to develop the commercial scale manufacturing process for the final product which will incorporateNutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system.-
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. -
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. 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.- 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.
The pivotal clinical study is a human abuse potential study performed to assess the impact of the potentially abuse-deterrent properties in a drug-experienced, recreational user population. The human abuse potential study is a randomized, double-blind, placebo-controlled and positive controlled crossover study comparing AVERSA Fentanyl to the currently marketed fentanyl patch which does not contain abuse-deterrent technology. The success of the human abuse potential study is based on the assessment drug liking using various instruments that are predictive of the likelihood of abuse.
(1) Health Advances Aversa Fentanyl market analysis report 2022
About
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.
About Kindeva
Headquartered in
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,'' "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain
For more information, contact:
Email: NTRB@Redchip.com
Phone: 1-407-644-4256
Address:
Phone: 407-377-6695
Email: Support@nutriband.com
SOURCE:
View the original press release on accesswire.com
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