Azstarys™ (serdexmethylphenidate and dexmethylphenidate), a novel treatment for attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older, has been made available by Corium, Inc.

Azstarys consists of serdexmethylphenidate, a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate. Each capsule of Azstarys contains a fixed molar ratio of 70% serdexmethylphenidate and 30% dexmethylphenidate. Treatment is administered once daily in the morning and may be taken either whole or the contents of the capsule may be opened and mixed with water or applesauce. 

Azstarys is supplied in 3 capsule strengths (serdexmethylphenidate/ dexmethylphenidate): 26.1mg/5.2mg, 39.2mg/7.8mg, and 52.3mg/10.4mg. It should not be substituted for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles and may have different methylphenidate base composition.

Approval of Azstarys was supported by data from a randomized, double-blind, placebo-controlled, analog classroom study (ClinicalTrials.gov: NCT03292952), which included 150 patients 6 to 12 years of age with ADHD. The efficacy of Azstarys in adults and pediatric patients 13 to 17 years of age was established by pharmacokinetic bridging between Azstarys and dexmethylphenidate hydrochloride extended-release capsules.


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Azstarys is classified by the US Drug Enforcement Administration as a Schedule II controlled substance.

Reference

Corium launches innovative ADHD treatment Azstarys™ (serdexmethylphenidate and dexmethylphenidate) in the U.S. for patients age 6 years and older. News release. Corium, Inc. Accessed July 21, 2021. https://www.prnewswire.com/news-releases/corium-launches-innovative-adhd-treatment-azstarys-serdexmethylphenidate-and-dexmethylphenidate-in-the-us-for-patients-age-6-years-and-older-301338086.html