FDA approves Adzenys extended-release orally disintegrating tablet for ADHD

The FDA recently approved Adzenys XR-ODT for the treatment of attention-deficit/hyperactivity disorder in children age 6 years and older, according to a press release.

“The novel features of an extended-release orally disintegrating tablet, which is dosed once daily and disintegrates in the mouth, make Adzenys XR-ODT attractive for use in both children (6 years and older) and adults,” Alice Mao, MD, medical director at Memorial Park Psychiatry, Houston, said in a press release.

Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablet, Neos Therapeutics) was approved by the FDA via the 505(b)(2) regulatory pathway.

Clinical analysis indicated that the amphetamine extended-release orally disintegrating tablet was bioequivalent to Adderall XR (amphetamine aspartate monohydrate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate, Shire Pharmaceuticals).

The most common adverse reactions, occurring in more than 5% of the study cohort, included loss of appetite, insomnia, abdominal pain, emotional liability, vomiting, nervousness, nausea and fever among children aged 6 to 12 years; loss of appetite, insomnia, abdominal pain and weight loss among adolescents aged 13 to 17 years; and dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia and urinary tract infections among adults.

The amphetamine extended-release orally disintegrating tablet will be available in six dosage strengths equivalent to the Adderall XR dosage strengths, allowing for individualization of dosage.