Nutriband presents data on incidence of transdermal patch abuse

Nutriband announced that data on the incidence of transdermal patch abuse and accidental pediatric exposure was presented at the 2024 American Academy of Pain Medicine Annual Meeting on March 8, 2024. The American Academy of Pain Medicine is dedicated to advancing multidisciplinary pain care, education, advocacy, and research. The data indicate that transdermal patch abuse and accidental pediatric exposures to patches continue to be a serious problem resulting in major medical outcomes and death, suggesting an unmet need for safer abuse-deterrent versions of transdermal patches containing drugs with a risk of abuse, misuse or accidental exposure. Nutriband’s lead product is AVERSA Fentanyl which combines Nutriband’s proprietary AVERSA abuse-deterrent transdermal technology with an already FDA-approved transdermal fentanyl patch and has the potential to become the world’s first opioid patch with abuse-deterrent properties.AVERSA Fentanyl is estimated to have the potential to reach peak annual US sales of $80M – $200M. Nutriband is developing its proprietary Aversa abuse-deterrent transdermal technology which can be incorporated into any transdermal patch that contains any drug with a risk of abuse, misuse or accidental exposure. Its Aversa product development pipeline includes abuse-deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure. Transdermal patches are designed to provide an alternative route of administration for opioid or stimulant drugs that are prescribed for treatment of conditions such as chronic pain, opioid use disorder or attention deficit/hyperactivity disorder. Although transdermal versions offer improved pharmacokinetic delivery as well as patient convenience with wear times of up to 7 days, they contain an increased drug payload which can often be a target for recreational drug abusers or subject to accidental pediatric exposure, particularly with infants and toddlers. Abuse of opioids, and in particular fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid containing transdermal products. According to the FDA, 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. The company engaged Rocky Mountain Poison & Drug Safety, a division of Denver Health and Hospital Authority, Denver, Colorado to determine the incidence of abuse and accidental pediatric exposure of transdermal patches containing drugs of abuse in the United States based on poison center data for the surveillance period 2018-2022. RMPDS utilized the Researched Abuse, Diversion and Addiction-Related Surveillance System, a surveillance system that collects real-world safety and effectiveness data about prescription drugs. Key findings from the study include: Major medical outcome or death resulted from a notable proportion of fentanyl and buprenorphine patch intentional exposures and accidental pediatric exposures; Two deaths were reported due to abuse of fentanyl transdermal patches; Oral abuse accounted for 62.5% of all intentional abuse/misuse event reports for fentanyl patches; A notable proportion of accidental pediatric exposures to transdermal formulations resulted in major medical outcomes.