FDA approves Azstarys to treat attention deficit hyperactivity disorder – Kem Pharma Inc

KemPharm, Inc. has announced that the FDA has approved the New Drug Application for Azstarys (formerly referred to as KP 415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older.

Azstarys consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Corium, Inc. a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of Azstarys per the definitive collaboration and license agreement (the “License Agreement”) between KemPharm and an affiliate of GPC. Corium expects to make Azstarys commercially available in the U.S. as early as the second half of 2021.