FDA Accepts KemPharm NDA for ADHD Drug

FDA has accepted for review a KemPharm NDA for its investigational product candidate KP415 (serdexmethylphenidate) for treating attention deficit hyperactivity disorder (ADHD). The company is expecting a user fee review action target of 3/2021.

Serdexmethylphenidate is KemPharm’s prodrug of d-methylphenidate (d-MPH) and was designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events, the company says. In addition, clinical trial data suggests that the prodrug alone may have lower abuse potential than relevant d-MPH comparators, it says.

KemPharm says Corium, Inc. will lead all commercialization activities for KP415, if approved. Corium is a contract manufacturer focused on specialty pharmaceutical products.