Posted by Michael Wonder on 03 Mar 2020
KemPharm submits KP415 NDA to the FDA for the treatment of ADHD
2 March 2020 - If approved, KemPharm believes that KP415 may address several unmet needs, including earlier onset of action and longer duration of therapeutic effect vs. other available methylphenidate products.
KemPharm today announced that it has submitted a New Drug Application under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its investigational product candidate, KP415, to the U.S. FDA.
KP415 is KemPharm’s product candidate for the treatment of attention deficit hyperactivity disorder (ADHD) which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).
