The New Drug Application (NDA) for viloxazine hydrochloride (SPN-812; Supernus Pharmaceuticals), a serotonin norepinephrine modulating agent, has been submitted to the Food and Drug Administration (FDA) for the treatment of pediatric patients with attention deficit hyperactivity disorder (ADHD).

The submission is supported by data from an extensive development program that included four phase 3 studies involving patients with ADHD aged 6 to 17 years. Findings from the studies showed viloxazine was effective in reducing the symptoms of hyperactivity/impulsivity and inattention on the ADHD Rating Scale-5 with improvements observed as early as week 1. 

In particular, the phase 3 P304 study demonstrated viloxazine 400mg achieved statistical significance in the primary end point (change from baseline in ADHD RS-5 total score; P=.0082). In addition, the 400mg dose reached statistical significant on the hyperactivity/impulsivity and inattention subscales, compared with placebo (P =.0484 and P =.0042, respectively). Moreover, compared with placebo, the 400mg dose met the Clinical Global Impression-Improvement (CGI-I) secondary end point (P =.0051).

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With regard to safety, viloxazine demonstrated a favorable profile that was consistent across all phase 3 studies with low occurrence of adverse events. The most common treatment-emergent adverse events were somnolence, fatigue, decreased appetite, headache and nausea.

“This NDA submission is an important milestone in the development of SPN-812, which if approved by the FDA, has the potential of becoming the first novel treatment to be introduced in the ADHD market in more than a decade,” said Jack A. Khattar, President and CEO of Supernus Pharmaceuticals. 

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The Company recently initiated a phase 3 study to evaluate the efficacy and safety of viloxazine for adults with ADHD.

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This article originally appeared on MPR