FDA expands approval of non-stimulant ADHD drug to adults

The Food and Drug Administration (FDA) has expanded its approval of a non-stimulant drug for ADHD, the first in about 20 years, to include adults along with children.

Viloxazine, sold commercially as Qelbree in extended-release capsules, has been approved to help treat ADHD in adults 18 and over, its maker, Supernus Pharmaceuticals, announced.

Qelbree was first approved for treating children ages 6 to 17 with ADHD last April. At the time, it was the first such drug approved in more than 10 years for children.

In a statement shared by Supernus, Greg Mattingly, physician and professor of psychopharmacology at the Washington University School of Medicine, said non-stimulant options for adults with ADHD have been very limited.

“This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms,” Mattingly said.

Viloxazine was once prescribed as an antidepressant in Europe before being abandoned in favor of newer drugs. Before last year, it had never been approved for use in the U.S.

As a treatment, Qelbree is taken once daily in doses between 200 mg and 600 mg. According to the FDA, side effects of this drug include an increased risk of suicidal thoughts or actions, increased blood pressure and heart rate, and manic episodes.

The most common side effects are milder and include decreased appetite, sleepiness and vomiting.

As a non-stimulant drug, Qelbree is less addictive and less likely to be abused. According to Supernus, no evidence of abuse potential was found during clinical trials.