KemPharm’s Azstarys Secures FDA Approval for ADHD

The FDA has approved KemPharm’s New Drug Application (NDA) for Azstarys, a once-daily prodrug, to treat attention deficit hyperactivity disorder (ADHD) in patients age six years and older.

Azstarys consists of serdexmethylphenidate, KemPharm’s prodrug of d-methylphenidate (d-MPH) co-formulated with immediate-release d-MPH.  Prodrugs are engineered to improve a drug’s bioavailability, extend its duration of action, reduce its susceptibility to abuse and/or increase safety.

KemPharm is eligible to receive up to $468 million in milestone payments as well as royalties from sales of the prodrug per its license agreement with Gurnet Point Capital (GPC). Corium, a biotech acquired by GPC, will lead the commercialization of Azstarys and plans to make the treatment commercially available in the U.S. as early as the second half of 2021.