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Azstarys is approved to treat patients 6 years and older.
Corium has launched Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), in the United States. The therapy is for the treatment of patients 6 years and older with attention deficit hyperactivity disorder (ADHD).
"The launch of Azstarys provides patients with ADHD, their caregivers, and their clinicians with a first-of-its-kind treatment that offers both rapid and extended ADHD symptom improvement because of the dual action of its formulation using the prodrug SDX with IR MPH," Perry J. Sternberg, president and chief executive officer of Corium, said in a statement.
The FDA approved Azstarys in March 2021. It is the first and only product containing SDX, an extended-release oral prodrug of d-MPH. It is available in three once-daily dosage strengths of SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg. The therapy is classified by the U.S. Drug Enforcement Administration as a Schedule II therapy.
After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day. It is designed to provide symptom control rapidly with the d-MPH and for an extended duration with SDX.
Company officials say this dual action addresses the unmet needs in the market, including early onset of action and long duration of therapy, with steady ADHD symptom control.
Azstarys was evaluated in a multicenter, double-blind, randomized, placebo-controlled, laboratory classroom phase 3 study in 150 children aged 6 to 12 years diagnosed with ADHD. The results of this study were presented in January 2021 at the American Professional Society of ADHD and Related Disorders Annual Meeting.
As of 2016, 6.1 million children aged 2-17 years living in the U.S. had been diagnosed ADHD, according to the CDC.