AZSTARYS®, An Innovative ADHD Treatment Developed by KemPharm, to be Featured in a Poster Presentation at the 2021 Psych Congress
Pharmacokinetic data from two clinical studies of AZSTARYS demonstrated its rapid onset of action and long duration of effect
AZSTARYS is a once-daily product for the treatment of ADHD in patients aged six years and older consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
The poster, titled, “Steady-State Pharmacokinetics and Relative Bioavailability of Serdexmethylphenidate/d-Methylphenidate, a Treatment for Attention-Deficit/Hyperactivity Disorder, Containing a Novel Prodrug of d-Methylphenidate,” detailed data from two separate pharmacokinetic studies. The first study compared the amount of d-MPH that reached systemic circulation (relative bioavailability) in 30 patients administered a single dose of AZSTARYS and a single dose of extended-release d-MPH hydrochloride (HCI). Data in the poster revealed that following a single dose of AZSTARYS (SDX/d-MPH capsules), d-MPH plasma concentrations increased rapidly and were sustained through late-day time points. This extended-duration exposure profile is governed by the unique properties of the prodrug, SDX, which is gradually converted to active d-MPH after reaching the intestinal tract.
The second study in the poster presentation highlighted data demonstrating that AZSTARYS administered once daily over a four-day period achieved steady-state d-MPH plasma concentration before the third daily dose of AZSTARYS. Steady-state pharmacokinetics is a metric used to determine the time it takes for drug levels to remain consistent in the body when administered continuously.
“We are pleased that data highlighting AZSTARYS were accepted for scientific presentation during the 2021
The studies presented at the 2021
About Attention Deficit Hyperactivity Disorder (ADHD):
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common mental disorders affecting children. ADHD also affects many adults. Symptoms of ADHD include inattention (not being able to keep focus), hyperactivity (excess movement that is not fitting to the setting) and impulsivity (hasty acts that occur in the moment without thought).1 An estimated 8.4% of children and 2.5% of adults have ADHD.23
AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.
The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
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2 Danielson, ML, et al. Prevalence of Parent-Reported ADHD Diagnosis and Associated Treatment Among
3 Simon V, Czobor P, Bálint S, et al: Prevalence and correlates of adult attention-deficit hyperactivity disorder: a meta-analysis. Br J Psychiatry194(3):204–211, 2009