
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
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2. D’Arrigo T.
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