Results of a pivotal phase III study of Supernus Pharmaceuticals‘ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics. This is the first of the trials to be published from the complete dossier that Supernus has submitted to the FDA for approval for the use of SPN-812 in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

The study met its primary endpoint, change from baseline in ADHD-RS-5 at the end of study. Specifically, children 6-11 years old with ADHD taking SPN-812 showed significant improvement in ADHD symptoms compared to those taking placebo. Overall, SPN-812 was well tolerated.

“We’re very encouraged by these findings because the ADHD landscape hasn’t seen a novel treatment in nearly a decade,” said Jonathan Rubin, MD, MBA, Senior Vice President Research & Development, Supernus Pharmaceuticals. “This is significant given the limitations of other FDA-approved nonstimulant and stimulant treatments. Patients and prescribers should have choices in the treatment of ADHD, especially if a medication is not working, causing unwanted adverse effects, or increasing the risk for inappropriate misuse by patients. SPN-812 could be a new option in the prescribers’ toolbox.”

SPN-812 is a novel non-stimulant in development for the treatment of ADHD. The FDA agreed to review the Supernus NDA for SPN-812 in January 2020 with a PDUFA target action date of Nov. 8, 2020.  

To view the full study published by Clinical Therapeutics, please click here