KemPharm's ADHD candidate meets in Phase III

KemPharm Inc. (NASDAQ:KMPH) said KP415 met the primary endpoint of improving classroom behaviors in the Phase III KP415.E01 trial to treat pediatric ADHD patients. The company reiterated plans to submit an NDA to FDA for KP415 in 1Q19.

The double-blind, U.S. trial enrolled 150 ADHD patients ages 6-12 to receive placebo or once-daily 34, 51 or 68 mg doses of oral KP415 for seven days following an open-label three-week dose optimization phase and two-day washout period...