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AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is available for prescription to help provide rapid and extended duration of attention-deficit/hyperactivity disorder (ADHD) symptoms.
Corium, Inc. announced that AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is now available for treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older.1 The therapy is 70% extended-release serdexmethylphenidate and dexmethylphenidate with 30% immediate release dexmethylphenidate. The therapy is available in 3 once-daily dosages: 26.1/5.2mg, 39.2/7.8mg, and 52.3/10.4 mg.
The therapy was approved by the US Food and Drug Administration in March 2021. The approval was based on a multicenter, double-blind, randomized, placebo-controlled, phase 3 study of 150 children aged 6 to 12 years who had been diagnosed with ADHD. The study found that there were significant improvements in the group treated with the therapy. No serious adverse events were noted in the study, but headache, upper abdominal pain, insomnia, and pharyngitis were more notable in the group receiving the treatment than the placebo group.
The therapy should not be used children who are allergic to serdexmethylphenidate, methylphenidate, or other ingredients in AZSTARYS as well as children who have taken or stopped taking within 2 weeks monoamine oxidase inhibitor. AZSTARYS is a controlled substance with the potential for abuse that may lead to dependence. Caregivers should put the drug in a safe place to prevent misuse.
1. Corium, Inc. Corium launches innovative ADHD treatment AZSTARYS (serdexmethylphenidate and dexmethylphenidate) in the US for patients age 6 years and older. Published July 21, 2021. Accessed July 22, 2021. https://www.corium.com/pdf/Corium_AZSTARYS_Now_Available_Press_Release_7-21-21.pdf