Qelbree

Viloxazine (Qelbree) for ADHD

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.

Supernus’ Qelbree (SPN-812) Receives the US FDA’s Approval for the Treatment of ADHD

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 …

Supernus’ Qelbree (SPN-812) Receives the US FDA’s Approval for the Treatment of ADHD Read More »

Supernus ADHD drug is FDA approved; first new ‘non-stimulant’ med in a decade

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.