Supernus Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SPN-812 for the treatment of patients with attention deficit hyperactivity disorder (ADHD).
SPN-812 is a well differentiated product candidate that, if approved by the FDA, can become a unique multi-symptom treatment option for many patients with ADHD. It is a non-controlled substance that is easy to use and that has shown in clinical studies a reduction in ADHD symptoms observed as early as week one and continued until the end of the studies.
“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 Chief Executive Officer of Supernus Pharmaceuticals. “In addition, SPN-812 represents the foundation on which we will be building a strong presence in psychiatry.”
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The NDA for SPN-812 includes data from an extensive development program consisting of four Phase III clinical trials that studied the pediatric patient population from the age of 6 to 17 years, two Phase II clinical trials, several Phase I trials, long-term open label extension study, preclinical testing, and drug manufacturing data.
In addition, we announced last week that we initiated a Phase III program to study SPN-812 in the adult ADHD patient population.
SPN-812 is a serotonin norepinephrine modulating agent (SNMA) that Supernus is developing as a novel non-stimulant for the treatment of ADHD. Based on data generated to date, the Company believes SPN-812 could be a well-differentiated ADHD treatment compared to other treatments for ADHD due to its novel mechanism of action and unique pharmacological and pharmacokinetic profile. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant.