ORLANDO, FL / ACCESSWIRE / July 15, 2024 / Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on July 9, 2024, for trademark application Serial Number 98117984, covering the mark "AVERSA™." The Notice of Allowance signifies that the USPTO is expected to grant a trademark registration for this application following the completion of administrative processes.

The AVERSA™ trademark is integral to Nutriband's platform technology which can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband's lead product under development is AVERSA™ Fentanyl, an abuse deterrent fentanyl transdermal system.

Nutriband, in partnership with Kindeva Drug Delivery, is progressing towards completing the scale-up of the commercial manufacturing process for AVERSA™ Fentanyl. This partnership has successfully moved from a feasibility agreement to a commercial development and clinical supply agreement aimed at manufacturing product for the upcoming human abuse potential clinical study. This study is crucial for the New Drug Application (NDA) that Nutriband plans to submit to the FDA.

Upon completion of the commercial manufacturing process, Nutriband will file an Investigational New Drug (IND) application with the FDA. This filing will precede the pivotal laboratory and clinical evaluations needed to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl, in line with FDA Guidance. The IND will include comprehensive chemistry, manufacturing, and controls (CMC) information and the clinical study protocol for the human abuse potential study.

The pivotal clinical study will involve a randomized, double-blind, placebo-controlled, and positive-controlled crossover design, comparing AVERSA™ Fentanyl to a currently marketed fentanyl patch without abuse-deterrent technology. This human abuse potential study will assess the drug's "liking" among recreational users, which is predictive of the likelihood of abuse. Preliminary studies have shown that AVERSA™ technology is highly resistant to physical and chemical manipulation, reinforcing its potential effectiveness as an abuse deterrent.

According to a market analysis report by Health Advances, AVERSA™ Fentanyl has the potential to reach peak annual U.S. sales of $80 million to $200 million. This reflects the significant impact that AVERSA™ technology could have on the market for abuse deterrent pharmaceutical products.

About AVERSA™ Technology

Nutriband's AVERSA™ abuse deterrent transdermal technology is designed to incorporate aversive agents into transdermal patches, deterring abuse by making the experience unpleasant. This technology is especially significant for drugs like fentanyl, which have a high potential for abuse. AVERSA™ aims to ensure that these essential medications remain accessible to patients who need them while enhancing their safety profiles. The AVERSA™ technology is supported by a robust intellectual property portfolio, with patents granted in the United States and several other countries including Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.

About Nutriband Inc.

Nutriband Inc. is primarily engaged in developing a portfolio of transdermal pharmaceutical products. The Company's lead product in development is an abuse deterrent fentanyl patch that incorporates AVERSA™ technology. This technology can be integrated 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.

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 Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2024 and Forms 10-Q, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

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