The US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for an investigational, immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) specifically designed to resist potential manipulation, Arbor Pharmaceuticals recently announced.
“Given the growth of nonmedical use of stimulant medications among the U.S. population, the development of a manipulation-resistant formulation of amphetamine is extremely important,” said Anthony Rostain, MD, chair of the Cooper University Healthcare Department of Psychiatry and Behavioral Health and professor emeritus of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “It’s a vital step in making these helpful medications safer to use in clinical practice.”
If approved, AR19 would be the first prescription ADHD stimulant medication designed to resist manipulation for nonmedical use, which could help deter misuse and abuse by intranasal, intravenous, and smoking routes of administration. Stimulant medications are the most commonly misused prescription drugs on college campuses, with 16% of 19,000 college students reporting nonmedical use in a 2018 national survey.
The FDA has set a Prescription Drug User Fee Act target action date of November 15, 2020. AR19 is intended to treat ADHD in children age 3 to 17 years and in adults age 18 years or older.
“While stimulants are essential first-line therapies for ADHD, they are associated with potentially dangerous risks and [adverse] effects when used nonmedically, especially via nonoral routes of administration,” said Evan Scullin MD, medical director of Arbor Pharmaceuticals. “Arbor has designed AR19 to resist manipulation to help address this public health concern of nonoral use, and we look forward to working closely with the FDA as it reviews our application.”
Arbor Pharmaceuticals announces FDA filing acceptance of New Drug Application (NDA) for AR19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for nonmedical misuse or abuse [press release]. Atlanta, Georgia: Arbor Pharmaceuticals; May 13, 2020.