24/7 BIOPHARMA - issue 1 / October 2024

NEWS

Nutriband licenses Bitrex ® brand aversive agent for its lead product – AVERSA™ fentanyl trandsdermal patch

Nutriband Inc. a company engaged in the development of prescription transdermal pharmaceutical products, 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 FDA [1] , 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

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 brand name 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] . 1. https://www.fda.gov/consumers/ consumer-updates/accidental exposures-fentanyl-patches continue-be-deadly-children 2. Health Advances Aversa Fentanyl market analysis report 2022 - Bitrex ® is a registered trademark of Macfarlan Smith Limited (a Veranova company). References

powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or