Supernus Announces FDA Acceptance for Review of New Drug Application for SPN-812 for the Treatment of ADHD

SPN-812 (viloxazine hydrochloride), a once-daily novel serotonin norepinephrine modulating agent (SNMA), demonstrates a reduction in ADHD-RS-5 total score as early as Week 1 and continuing until the end of the pivotal clinical studies

ROCKVILLE, Md., Jan. 21, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has found the New Drug Application (NDA) for SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD) acceptable for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 8, 2020.  

“SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “This is critical for the nearly 6.1 million children and adolescents in the U.S. who are diagnosed with the condition and are in need of a treatment that is a non-controlled substance and that works differently from currently available treatments.”

The NDA for SPN-812 is based on 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, a long-term open label extension study, preclinical testing, and drug manufacturing data.  Each of the four pivotal clinical trials showed a reduction in ADHD-RS-5 total score as early as Week 1 and continuing until the end of the clinical study, as well as improvement in both hyperactivity/impulsivity and inattention subscales.  The effect was statistically significant for the studies for 100mg, 200mg, and 400mg doses.  SPN-812 had an acceptable safety profile with low incidence of adverse events and low discontinuation rates.

In addition, during the fourth quarter of 2019, the Company initiated a Phase III program to study SPN-812 in the adult ADHD patient population.

About SPN-812

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.