Viloxazine for treatment of ADHD

May 8, 2021 0 By FM

Supernus Pharmaceuticals announced that the US FDA approved viloxazine extended-release capsules (Qelbree) for the treatment of attention-deficit hyperactivity disorder (ADHD) in paediatric patients 6 to 17 years of age.

The approval of viloxazine is supported by data from an extensive development programme consisting of four phase III clinical trials that studied more than 1000 paediatric 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 viloxazine in adults in the second half of 2021.