KemPharm Announces Top Line Results from KP415.E01 Efficacy and Safety Trial in Children With ADHD

KemPharm (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced top line results from a pivotal efficacy and safety clinical trial of KP415, its investigational attention-deficit/hyperactivity disorder (ADHD) product candidate that contains serdexmethylphenidate (a prodrug of d-methylphenidate) and d-methylphenidate.

As quoted in the press release:

The trial was a multicenter, randomized, parallel, double-blind, placebo-controlled analog laboratory classroom clinical trial in 150 children aged 6-12 years old with a diagnosis of ADHD to assess the efficacy and safety of KP415. Subjects who received KP415 met the trial’s primary and secondary efficacy endpoint, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale.

“We are pleased with these top line results from our pivotal trial of KP415.  The trial met its pre-specified primary endpoint, which is the mean difference in the SKAMP-Combined score change from baseline across all post-dose time points,” said Travis Mickle, Ph.D., KemPharm President and Chief Executive Officer.  “Pre-specified secondary endpoints of SKAMP-C change at each time point from the pre-specified, pre-randomization baseline indicated a drug effect from 1 to 10 hours post-dose, and data from the PERMP, PERMP-Attempted and PERMP-Correct all exhibited improvement over placebo from 0.5 hours to 13 hours post-dose.  Lastly, KP415 was generally well-tolerated with adverse events (AEs) typical of stimulant therapy.”

Click here to read the full press release.