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FDA approves Adzenys XR-ODT for ADHD.

An amphetamine-based extended-release orally disintegrating tablet for patients aged 6 years and older diagnosed with attention-deficit/hyperactivity disorder won Food and Drug Administration approval.

Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet for ADHD, Neos Therapeutics, the drug's manufacturer, said in a statement. The newly approved agent is bioequivalent to Adderall XR, and patients taking Adderall can be switched to the new drug. Equivalent doses of the two drugs are outlined on the drug label.

"The novel features of an extended-release orally disintegrating tablet ... make Adzenys XR-ODT attractive for use in both children (6 and older) and adults," Dr. Alice R. Mao, medical director, Memorial Park Psychiatry, Houston, said in the statement.

As a condition of the approval, Neos Therapeutics must report the status of three postmarketing studies annually of children diagnosed with ADHD taking Adzenys XR-ODT, according to the approval letter. One is a single-dose, open-label study of children aged 4 years to under 6 years; the second is a randomized, I double-blind, placebo-controlled titration study of children aged 4-5 years; and the third is a 1-year, open-label safety study of patients aged 4-5 years.

For patients aged 6-17 years, the starting dose is 6.3 mg once daily in the morning, and for adults, it is 12.5 mg once daily in the morning, according to the label. The medication will be available in four other dose strengths: 3.1 mg, 9.4 mg, 15.7 mg, and 18.8 mg.

The most common adverse reactions to the drug among pediatric patients include loss of appetite, insomnia, and abdominal pain. Among adult patients, adverse reactions include dry mouth, loss of appetite, and insomnia.

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Author:Henderson, Gina L.
Publication:Pediatric News
Date:Mar 1, 2016
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