> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts KemPharm NDA for ADHD Drug
- URL: https://www.fdaweb.com/fda-accepts-kempharm-nda-for-adhd-drug/
- Published: 2020-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:13:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146711

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.