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FDA Approves Adhansia XR for ADHD

Adlon Therapeutics news release; 2019 Mar 1

Adlon Therapeutics LP, a subsidiary of Purdue Pharma LP, has announced that the US Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged ≥6 years. In the US, Purdue Pharma LP is headquartered in Stamford, CT.

Dosage and administration: Recommended starting dose for patients ≥6 years is 25 mg once daily in the morning. Dosage may be increased in increments of 10 to 15 mg at intervals of at least 5 days. The capsules can be administered with or without food. Capsules may be swallowed whole or opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. If sprinkled, the contents should be taken without crushing or chewing.

Adverse reactions: The most common (≥5% and twice the rate of placebo) adverse reactions

occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and weight decrease.


Adlon Therapeutics L.P. announces FDA approval for Adhansia XR (methylphenidate HCl) extended-release capsules CII for the treatment of ADHD. [news release]. Stamford, CT: Purdue Pharma LP. March 1, 2019. Accessed March 8, 2019.