ADHD News & Research

FDA Approves New ADHD Medication from KemPharm

The FDA has approved a new stimulant ADHD medication from KemPharm called AZSTARYS, a once-daily methylphenidate treatment for patients age six years and older.

March 5, 2021

A new ADHD medication has gained approved from the U.S. Food and Drug Administration (FDA). KemPharm’s AZSTARYS™, a once-daily methylphenidate stimulant medication previously known as KP415, has been approved by for the treatment of attention deficit hyperactivity disorder (ADHD or ADD) in individuals aged six years and older. AZSTARYS could be commercially available in the U.S. as early as the second half of 2021.

AZSTARYS™ is a central nervous system (CNS) stimulant consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. The medication, which comes in capsule form, should be taken orally once a day in the morning.

Ann Childress, M.D., an investigator in the AZSTARYS™  clinical trial and President of the Center for Psychiatry and Behavioral Medicine in Las Vegas, said “three properties are repeatedly cited by patients and their caregivers as being underserved by current ADHD medications: onset of action, duration of effect, and consistency of therapy. Having investigated AZSTARYS™ and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.”1

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1KenPharm. KemPharm announces FDA approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once-daily treatment for ADHD. News release. March 2, 2021. https://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html

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