The US Food and Drug Administration (FDA) has approved a new, once-daily oral stimulant medication for treatment of attention deficit hyperactivity disorder (ADHD) in people aged 6 years and older.
Azstarys (KemPharm, Inc) combines extended-release serdexmethylphenidate (SDX), KemPharm’s prodrug of dexmethylphenidate (d-MPH), coformulated with immediate-release d-MPH.
Following absorption in the gastrointestinal tract, SDX is converted to d-MPH, which is gradually released throughout the day, providing symptom control both rapidly with the d-MPH and for an extended duration with SDX.
The dual-action of Azstarys addresses an unmet need for a medication that has early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule, stated Corium Inc, the company that will lead US commercialization of the drug, in a news release.
“The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with d-methylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” said Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, Nevada, who led the phase 3 trial of the drug, in the release.
The study included 150 children aged 6 to 12 years with ADHD. Compared with placebo, treatment with Azstarys led to significant improvement in ADHD symptoms, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale – Combined (SKAMP-C) scores averaged over 13 hours.
Adverse events seen more often with Azstarys than placebo were headache (5.4% vs. 1.3%), upper abdominal pain (4.1% vs. 1.3%), insomnia (2.7% vs. 1.3%) and pharyngitis (2.7% vs. 0%). No serious adverse events were reported.
The FDA has recommended a schedule II controlled substance classification for Azstarys and the US Drug Enforcement Administration (DEA) will decide on scheduling within 90 days.
Pending the DEA’s action, the launch of Azstarys is anticipated this summer.
Azstarys will be 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.
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