FDA Green-lights Neos Therapeutics' ADHD Drug

(RTTNews) - Neos Therapeutics Inc.'s (NEOS) Adzenys XR-ODT has been approved by the FDA for the treatment of attention deficit hyperactivity disorder, or ADHD, in patients six years and older.

ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity), according to the National Institute of Mental Health.

Adzenys XR-ODT, formerly known as NT-0202, becomes the first and only approved extended-release orally disintegrating tablet for the treatment of ADHD.

Approved via the 505(b)(2) regulatory pathway, Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR), one of the most commonly prescribed medications for the treatment of ADHD.

The launch and product shipments of Adzenys XR-ODT will begin in the second quarter of 2016, according to the company. The drug will be available in six dosage strengths.

NEOS closed Wednesday's trading at $9.42, up 0.86%. In after hours, the stock was up 16.45% to $10.97.