Press release
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 CELEBRATION, Fla., Oct. 27, 2021
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Pharmacokinetic data from two clinical studies of AZSTARYS demonstrated its rapid onset of action and long duration of effect CELEBRATION, Fla., Oct. 27, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that research involving AZSTARYS® is being featured in a poster presentation during the 2021 Psych Congress being held both virtually and in-person in San Antonio, Texas, from October 29 through November 1, 2021. The presentation highlights data from clinical studies assessing the relative bioavailability and the steady-state pharmacokinetics (PK) of AZSTARYS. 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. Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), is commercializing AZSTARYS in the U.S. 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 sci...