Supernus Pharma (NASDAQ:SUPN) announced top-line results from P304, its Phase 3 study of SPN-812 in adolescents with attention deficit hyperactivity disorder (ADHD).
SPN-812 is a non-stimulant serotonin norepinephrine modulating agent. P304’s primary outcome measure was the change in ADHD-RS-5 total score from baseline to the end of the study. For seven weeks, subjects received a daily dose of either 600 mg, 400 mg, or placebo. Consistent with Supernus’ previous Phase 3 studies, the 400 mg dose reached statistical significance.
Jack Khattar, president and CEO said, “We now have robust data on 100 mg, 200 mg and 400 mg doses from all four Phase 3 clinical trials with SPN-812 in patients with ADHD. The data are consistent in showing a clinically meaningful reduction in the symptoms of ADHD, with a favorable safety and tolerability profile.”
In December 2018, Supernus announced positive results from three Phase 3 studies of SPN-812, two involving children (P301 and P303) and one involving adolescents (P302) with ADHD.
Supernus plans to file a new drug application for SPN-812 with the FDA in the second half of 2019.