Supernus Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
Supernus says that Qelbree offers a new alternative for the treatment of ADHD as it is not a controlled substance yet it has proven efficacy and a tolerable safety profile.
This approval offers a novel once a day sprinkleable non-stimulant that can be used by children and adolescents with ADHD.
The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1,000 pediatric patients from the age of 6 to 17 years. In December 2020, the company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.
Read the Supernus statement