FDA accepts KenPharm’s IND application for ADHD prodrug

The U.S. Food and Drug Administration has accepted KenPharm's Investigational New Drug (IND) application for KP415, the company’s extended release d-threomethylphenidate (d-MPH) prodrug that was developed to treat attention deficit hyperactivity disorder (ADHD).

“We are very pleased that the FDA accepted our IND request for KP415, our co-lead product candidate, and expect to advance this program through proof-of-concept before year-end and into human clinical trials,” KemPharm President and CEO Dr. Travis Mickle said. “Based on our estimates, in 2015, methylphenidate accounted for approximately 19.7 million prescriptions and $4.2 billion in sales in the ADHD market. However, patent expiration in the ADHD space is eroding the revenues of branded products. We believe KP415 offers the opportunity to address this market dynamic with a prodrug technology that, in pre-clinical studies, has demonstrated both extended release properties and a pharmacokinetic profile that could enable a more predictable therapy compared with currently available, immediate-release d-MPH products.”

KemPharm’s immediate plans involve beginning and completing human trials before the end of this year, with more clinical trials beginning in the first half of 2017. The company also plans on submitting a New Drug Application in 2018.