FDA Okays First Orally Disintegrating Tablet for ADHD in Kids

Caroline Cassels

January 28, 2016

The US Food and Drug Administration (FDA) has approved an amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older. According to the drug company, Neos Therapeutics, the drug "is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD."

Adzenys XR-ODT was approved by the FDA on the basis of data demonstrating that the drug is the bioequivalent of a previously approved mixed amphetamine salts extended-release capsule (Adderall XR, Shire), one of the most commonly prescribed medications for the treatment of ADHD. Adzenys XR-ODT will be available in six dosage strengths, equivalent to the Adderall XR dosage strengths, thus allowing healthcare providers to individualize the dose.

According to a company, stimulant medications such as amphetamine and methylphenidate are the standard of care for treating ADHD. It notes that most of the existing treatment formulations are in the form of a tablet or capsule that needs to be swallowed intact or, in some cases, sprinkled on certain foods or fluids and ingested immediately. Orally disintegrating tablets differ from traditional tablets and capsules in that they are designed to disintegrate in the mouth, rather than being swallowed whole.

"This first ever FDA approval of a product using our proprietary extended-release, orally disintegrating tablet technology is an important milestone for Neos. We believe that Adzenys XR-ODT will provide an important innovation for treatment in the ADHD market, and we intend to begin educating healthcare providers about our exciting new product immediately," said Vipin K. Garg, PhD, president and CEO of Neos Therapeutics.

The company notes that product shipments will begin in the second quarter of 2016.


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