Supernus' ADHD candidate meets in Phase III in adolescents

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) said on Dec. 20 that both doses of SPN-812 met the primary endpoint in the Phase III P302 trial to treat adolescents with ADHD. The company reiterated its plans to submit an NDA to FDA in 2H19 for the selective norepinephrine reuptake inhibitor (SNRI) to treat ADHD.

The double-blind, U.S. trial enrolled 310 ADHD patients ages 12-17 to receive placebo or once-daily 200 or 400 mg oral SPN-812. On the primary endpoint, SPN-812 significantly reduced ADHD Rating Scale-5 (ADHD-RS-5) total score from baseline to week six by 16 points at the 200 mg dose (p=0.0232) and by 16.5 points at the 400 mg dose (p=0.0091) vs. 11.4 points for placebo...