FDA Approves Supernus's Qelbree For Treatment Of Attention-deficit Hyperactivity Disorder

(RTTNews) - Supernus Pharmaceuticals Inc. (SUPN) said that the U.S. Food and Drug Administration approved Qelbree or viloxazine extended-release capsules for the treatment of attention-deficit hyperactivity disorder or ADHD in pediatric patients 6 to 17 years of age.

Supernus plans to make Qelbree available in the U.S. in the second-quarter of 2021.

The approval of Qelbree was supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 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.