Company targeting FDA submission in the first half of 2024
AVERSA™ Fentanyl is the flagship product of the Company's AVERSA™ Platform
ORLANDO, FL / ACCESSWIRE / July 14, 2023 / Nutriband Inc. ("Company") (NASDAQ:NTRB)(NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that it has expanded its existing Credit Line facility to $5 Million USD to fund the continued development and regulatory submission process for the Company's patented lead product platform, AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal system. The Company is targeting FDA submission for AVERSA™ Fentanyl in the first half of 2024. AVERSA Fentanyl is the flagship product of the Company's AVERSA™ Platform.
AVERSA™ Fentanyl combines Nutriband's proprietary AVERSA™ abuse-deterrent transdermal technology and Kindeva Drug Delivery's FDA-approved transdermal fentanyl patch system. AVERSA™ Fentanyl was recently estimated to have the potential to reach peak annual US sales of $80M - $200M.1
"This increase in our credit facility allows us to reach key milestones in our regulatory strategy for AVERSA™ Fentanyl," said Gareth Sheridan, Nutriband CEO." "Securing non-dilutive funding that facilitates the advancement of our regulatory and commercial plans is a key component in fulfilling our goal of creating and maintaining value for our shareholders."
Nutriband's AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to help prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these kinds of treatments remain accessible to patients that really need them. The technology is covered by a broad intellectual property portfolio in 45 countries with patents granted in the United States, Europe, UK, Japan, Korea, Russia, Canada, Mexico, and Australia.
1 Health Advances market analysis report 2022
About Nutriband Inc.
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 website or any other website is not part of this press release.
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 10-K for the year ended January 31, 2023, filed April 26, 2023, and the Forms 10-Q for that fiscal year filed subsequent thereto 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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SOURCE: Nutriband Inc.