FDA Approves First Extended-Release Orally Disintegrating Tablet for ADHD

Adzenys XR-ODT is bioequivalent to Adderall XR

The FDA has given the green light to Adzenys XR-ODT (Neos Therapeutics) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 years of age and older. With this approval, the product is the first extended-release orally disintegrating tablet (ODT) for this indication.

Adzenys XR-ODT contains amphetamine loaded onto a mixture of immediate-release and polymer-coated, delayed-release resin particles. The treatment is patent-protected and is not a generic version of mixed amphetamine salts extended-release (MAS-XR) capsules.

The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved MAS-XR capsule (Adderall XR, Shire), one of the most commonly prescribed medications for the treatment of patients with ADHD. Adzenys XR-ODT will be available in six dosage strengths equivalent to the Adderall XR dosage strengths.

According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. It is estimated to affect 5% of children and 2.5% of adults in the U.S. Symptoms include inattentiveness, hyperactivity, and impulsiveness.

Stimulant medications, such as amphetamine and methylphenidate, are the standard of care for patients with ADHD, and extended-release formulations of these medications allow once-daily dosing. Most of the currently used treatment formulations are tablets or capsules. ODTs differ from traditional tablets and capsules in that they are designed to disintegrate in the mouth, rather than being swallowed whole.

Source: Neos Therapeutics; January 27, 2016.