The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for AR19 (Arbor Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥3 years. 

AR19 is an investigational immediate-release, amphetamine formulated to prevent the manipulation of the pellets in the capsules for nonmedical use. The formulation is intended to deter misuse and abuse via non-oral administration methods (ie, intranasal, intravenous and smoking).

The NDA is supported by a clinical program that includes studies evaluating the safety and efficacy of the treatment in both adult and pediatric patients, as well as data establishing the manipulation-resistant properties of the product. A study evaluating the pharmacokinetics of AR19 showed that the treatment was bioequivalent to a reference racemic amphetamine sulfate drug (Evekeo). Moreover, the study revealed that the bioavailability of AR19 was not impacted by meals or by sprinkling the contents of the capsules onto food. 

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“While stimulants are essential first-line therapies for ADHD, they are associated with potentially dangerous risks and side effects when used nonmedically, especially via non-oral routes of administration,” said Evan Scullin MD, Medical Director, Arbor Pharmaceuticals. “Arbor has designed AR19 to resist manipulation to help address this public health concern of non-oral use, and we look forward to working closely with the FDA as it reviews our application.”

A Prescription Drug User Fee Act (PDUFA) target date of November 15, 2020 has been set for this application.

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