FDA OKs Novel Dual-Action Stimulant Med For ADHD
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The US Food and Drug Administration (FDA) has approved a new, once-daily oral stimulant medication for the 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), co-formulated with immediate-release d-MPH.

Azstarys addresses an unmet need for a medication that has an early onset of action and a long duration of therapy, with steady ADHD symptom control in one capsule. After absorption in the gastrointestinal tract, SDX is converted to d-MPH.

"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.

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, upper abdominal pain, insomnia, and pharyngitis. No serious adverse events were reported. FDA has recommended a schedule II controlled substance classification. DEA will decide on the schedule within 90 days.

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