The company reported that KP415, which consists of serdexmethylphenidate and d-methylphenidate, met the primary efficacy endpoint in people with attention-deficit/hyperactivity disorder between the ages of 6 and 12 years.
KemPharm’s KP415 capsule makes use of d-MPH hydrochloride as an immediate release therapy and serdexmethylphenidate (a prodrug of d-MPH) as an extended-duration therapy. In the 150-person trial, participants received daily oral doses of either 28/6 mg SDX/d-MPH, 42/9 mg SDX/d-MPH or 56/12 mg SDX/d-MPH, corresponding to equivalent d-MPH amounts of 20, 30 and 40 mg, according to KemPharm.
Researchers optimized the dose of KP415 during a 3-week open-label phase of the trial. From there, participants were randomized to seven days of double-blind treatment with their optimized dose of KP415 or placebo.
“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,” KemPharm president & CEO Travis Mickle said in prepared remarks.
“We anticipate developing additional clinical data for KP415 throughout 2018, including the completion of our ongoing oral and intranasal Human Abuse Potential studies,” Mickle added. “We believe that completing the analysis of the full data set from KP415.E01 trial and these other studies will allow us to submit our New Drug Application for KP415 with the FDA in the first quarter of 2019.”
KMPH shares were trading at $6.65 apiece in premarket activity at the time of publication, down -1.5%.