KemPharm initiates pivotal efficacy trial of KP415
KemPharm reported the successful initiation of a "classroom-style" pivotal efficacy trial of KP415, the company's extended release, or ER, d-methylphenidate, or d-MPH, prodrug composition product candidate for the treatment of Attention Deficit, Hyperactivity Disorder, or ADHD. The trial is designed to support a potential label for KP415 for both an early onset and long duration of a KP415 treatment effect in ADHD patients. The trial is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom trial with children aged 6 to 12 years with a diagnosis of ADHD. Screening for pediatric trial patients began on November 20, 2017. Treatment with the study drug was initiated in the first patient on December 20, 2017. Enrollment in the trial is expected to total approximately 140 patients across five clinical sites in the United States, and it is anticipated that all patients will have completed the trial by the end of second quarter of 2018. Each patient will be treated for a total of four weeks.