FDA Approves Novel Nonstimulant for Treatment of ADHD in Adults

Approval comes 1 year after the drug was approved for the treatment of ADHD in children and adolescents.

The US Food and Drug Administration (FDA) has approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults.

This approval marks an expanded indication for Qelbree, a novel nonstimulant developed by Supernus Pharmaceuticals,1 as the FDA approved the drug for the treatment of ADHD in children and adolescents aged 6 to 17 in April 2021.2 Approval for its treatment of ADHD in adults aged 18 and older is based on positive results obtained by a randomized, double-blind, placebo-controlled Phase III study in adults with ADHD.1

Qelbree is reported to have a proven tolerability and safety profile and no evidence of abuse potential, and it has shown symptom improvement and efficiency early in treatment. Its approval is the first FDA approval of a novel nonstimulant treatment specifically for adults with ADHD in 20 years.1

“Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just 1 year after the approval of Qelbree to treat pediatric patients,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals, in a press release. “We are proud to bring a new novel nonstimulant option for adults into the market after 2 decades.”

References

1. Supernus announces FDA approval of Qelbree for the treatment of ADHD in adults. News release. Supernus Pharmaceuticals. May 2, 2022. Accessed May 3, 2022.

2. D’Arrigo T. FDA approves Qelbree for ADHD. News release. Psychiatric News. May 20, 2021. Accessed May 2, 2022.