Nutriband signs trademark licensing agreement for Bitrex® brand denatonium benzoate, the most bitter substance in the world, as an aversive agent for its Aversa™ Fentanyl abuse deterrent fentanyl transdermal patch
Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products
ORLANDO, FL / ACCESSWIRE / September 20, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed a trademark licensing agreement for the use of Bitrex® brand denatonium benzoate as an aversive agent in its lead product, AVERSA™ Fentanyl, an abuse deterrent fentanyl patch.
Nutriband's AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to 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 drugs remain accessible to those patients who really need them.
According to the FDA1, accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or sticking the patches on their skin. This can cause death by slowing the child's breathing and decreasing the levels of oxygen in their blood.
Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents.
Bitrex® is the leading brand for denatonium benzoate, the most bitter substance in the world. The extremely bitter taste makes products taste so bad that it makes children and adults who put them in their mouth want to spit them out immediately. This reaction is the body's natural response to bitter tastes, which has evolved over millions of years to help protect us from eating foods or materials which may be harmful. Children are particularly sensitive to bitter tastes which is why Bitrex® is so effective at helping prevent accidental ingestion and poisonings in young children.Bitrex® has been proven to be safe and effective in many products including household cleaners, pesticides, automotive products, laundry detergent, pens, paint, and batteries that are approved and sold all over the world.
Nutriband is currently working with its partner Kindeva Drug Delivery (Kindeva), a leading global contract development and manufacturing organization focused on drug-device combination products, to develop the commercial scale manufacturing process to incorporate Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system.
AVERSA Fentanyl has the potential to be the world's first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.2
2 Health Advances Aversa Fentanyl market analysis report 2022
Bitrex® is a registered trademark of MacFarlan Smith Limited (a Veranova company).
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to 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 drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.
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-deterrent 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 Bitrex®
Bitrex® is the leading brand of denatonium benzoate, the most bitter substance yet discovered. It is inert and odorless, but only tiny amounts are needed to make products taste unpalatable. Just one teaspoon of Bitrex® in an Olympic swimming pool is enough to make the water taste bitter! Children are particularly sensitive to bitter tastes, making Bitrex® a powerful deterrent to accidental swallowing and poisoning. Bitrex® is manufactured by Macfarlan Smith Limited (a Veranova company) who partners with global brands to help make their products safer and protect children from accidental exposure to potentially toxic substances. Bitrex® can be found in many products including household cleaners, pesticides, automotive products, laundry detergent, pens, paint, and batteries that are approved and sold all over the world.
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization focused on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K.
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, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, 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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SOURCE: Nutriband, Inc.