Date: June 28, 2021 Issue #: 1627 Summary: The FDA has approved viloxazine extended-release capsules (Qelbree – Supernus) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. Viloxazine is the second selective norepinephrine reuptake inhibitor to be approved in the US for treatment of ADHD; atomoxetine (Strattera, and generics) was approved in 2002.
Shots: The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients aged 6 to 17 yrs. with ADHD The program demonstrated the proven efficacy and a tolerable safety profile. In Dec’2020, the company reported the results from the P- III trial …
FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s a different formulation of a drug that was first approved in Europe decades ago.