ADHD News & Research

New Extended-Release, Orally Disintegrating ADHD Medication Released

Adzenys, a new ADHD stimulant medication that dissolves in the mouth, is now available in the United States and approved for patients 6 and older.

May 19, 2016

Neos Therapeutics has announced the U.S. release of Adzenys XR-ODT, the first orally disintegrating medication for the treatment of ADHD in patients 6 and older.

The medication, an amphetamine, comes in the form of an orange-flavored tablet that dissolves in the mouth when taken with or without water. Adzenys XR-ODT is formulated for once daily dosing, Neos says, using two different kinds of “micro-particles” that dissolve at different rates. Fifty percent dissolve immediately upon the medication’s administration, while the other 50 percent dissolve slowly to release the medication steadily throughout the day.

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Adzenys XR-ODT was approved by the Food and Drug Administration in January of 2016, after Neos presented data showing it is the bioequivalent of Adderall XR, a previously approved amphetamine medication. Adzenys XR-ODT will be available in six dosage strengths: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. For children, the recommended starting dose is 6.3 mg, to be titrated up to a maximum of 18.8 mg at weekly intervals. For adults, the recommended daily dose is 12.5 mg. Patients who are already being treated with Adderall XR can use a comparison chart, available on the Adzenys XR-ODT website, to convert their current dose of Adderall to a dose of Adzenys XR-ODT.

Click here for the FDA-required patient information on Adzenys XR-ODT.

Side effects of Adzenys XR-ODT are reportedly similar to Adderall and other stimulant medications, and include decreased appetite, difficulty sleeping, and stomach pain or nausea. In teenagers between the ages of 13 and 17, weight loss has been reported as a possible side effect, while adults may see an increase in urinary tract infections, according to a company press release.

Though Adzenys XR-ODT is its first branded ADHD medication, Neos is also pursuing FDA approval for two more formulations.

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“Neos is committed to addressing individual patient needs by delivering new treatment options for those with chronic disorders like ADHD,” said Vipin Garg, Ph.D., President and CEO of Neos, in a statement.