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Company Resubmits Application for Amphetamine Extended-Release, Orally Disintegrating Tablets to Treat ADHD

FDA response expected within 6 months

A new drug application for NT‐0202 (Neos Therapeutics), an amphetamine extended-release, orally disintegrating tablet (XR-ODT), has been resubmitted to the FDA for the treatment of patients with attention-deficit/hyperactivity disorder (ADHD).

The NDA resubmission provides information to address an FDA-issued complete response letter received in September 2013. The new information includes results from an additional pharmacokinetic study of NT-0202, which used a commercial-scale manufacturing process, and requisite stability data. The class 2 resubmission has a target 6-month Prescription Drug User Fee Act (PDUFA) review period. If approved, NT-0202 would be the first amphetamine XR-ODT for patients with ADHD. A methylphenidate XR-ODT candidate, Cotempla XR‐ODT (Neos Therapeutics), is currently under review by the FDA and, if approved, would be the first methylphenidate XR‐ODT available for ADHD.

Stimulant medications, such as methylphenidate and amphetamine, are the standard of care for treating patients with ADHD, and XR formulations of these medications allow once‐daily dosing. However, recent data suggest that a significant percentage of the pediatric population have difficulty swallowing solid dosage forms, and many remain uncomfortable doing so into adulthood. ODTs differ from traditional tablets and capsules in that they are designed to disintegrate on the tongue without the need for water, rather than being swallowed whole.

According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Its symptoms include difficulty staying focused and paying attention, difficulty controlling behaviour, and hyperactivity.

Source: PipelineReview; July 30, 2015.

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