FDA clears long-acting ADHD drug

February 3, 2016

FDA has approved amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT, Neos Therapeutics, Inc.) for the treatment of ADHD in patients 6 years and older.

FDA has approved amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT, Neos Therapeutics, Inc.) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older.

ADHD is one of the most common neurodevelopmental disorders of childhood, in which a patient may have trouble paying attention, controlling impulsive behaviors, or be overly active. Although it is most commonly diagnosed in children, ADHD often continues into adulthood.

Related: FDA approves chewable pill for ADHD

Adenyz XR-ODT is a central nervous system stimulant medication that promotes the release of catecholamines, specifically dopamine and norepinephrine, while also blocking their subsequent reuptake. Increasing the availability of these catecholamines is thought to improve attention spans, decrease distractibility, and decrease impulsivity in patients with ADHD. 

Adzenys XR-ODT contains amphetamine loaded onto a mixture of immediate release and polymer-coated, delayed-release resin particles. Orally disintegrating tablets differ from traditional dosage forms, such as tablets and capsules, in that they are designed to disintegrate in the mouth, rather than being swallowed whole. In addition to the ease of administration in pediatric patients, the extended-release formulation also allows for once-daily dosing. Adzenys XR-ODT will be available in six dosage strengths, allowing individualization of the dose.

“Adzenys XR-ODT was approved based on a clinical program that demonstrated bioequivalence to Adderall XR [Shire], a previously approved mixed amphetamine salts extended-release capsule and one of the most commonly prescribed medications for the treatment of ADHD,” said Tom McDonnell, chief commercial officer of Neos Therapeutics.

Related: Adults surpass kids for ADHD scripts

The new drug gives formulary managers and their patients “access to an important new innovation in the market, the first ever extended-release, oral disintegrating tablet,” McDonnell said.

Neos Therapeutics is  working now to discuss pricing with its customers, and will announce the price as the drug gets ready to launch in the second quarter of this year, according to McDonnell.

The most common adverse reactions associated with the use of Adzenys XR-ODT in children aged 6 to 12 years includes loss of appetite, insomnia, and abdominal pain. In adults, additional side effects include anxiety, agitation, and tachycardia. Adzenys XR-ODT is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or have taken an MAOI within the past 14 days, as hypertensive crisis can occur. 

Read more: More US adults relying on ADHD meds