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The FDA has approved the New Drug Application for a once-daily ADHD treatment.
The US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for KemPharm’s AZSTARYS™, previously known as KP415, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
AZSTARYS, a once-daily product, consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
“The FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,” Travis C. Mickle, PhD, President and CEO of KemPharm, told the press. “Today’s approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT® platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug.”1
Leading the commercialization of AZSTARYS is Corium, a portfolio company of Gurnet Point Capital (GPC), as per the definitive collaboration and license agreement between KemPharm and an affiliate of GPC. AZSTARYS could be commercially available in the US as soon as late 2021.
“Today’s approval by the FDA is met with great excitement for this innovative new ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults,” said Perry Sternberg, CEO of Corium. “Our team is mobilized to put our commercial plans into action as the approval of the AZSTARYS NDA now enables us to finalize our preparations for commercial launch as early as the second half of this year.”1
“We look forward to continuing our support of Corium as they forge ahead with the commercial launch of AZSTARYS,” Mickle said further.1
Ann Childress, MD, an investigator in the AZSTARYS clinical trial and President of the Center for Psychiatry and Behavioral Medicine, is excited about this new development. She had this to say on the NDA approval: “The ADHD industry, and specifically the MPH space, has seen little innovation in recent years, leaving prescribers and patients desiring new treatment options. In my research and practice, 3 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
1. KenPharm. 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