FDA Approves Qelbree for ADHD in Adults

Qelbree is the first new nonstimulant to be approved in 20 years.

The FDA has approved the supplemental new drug application for Qelbree (viloxazine) to treat adults with attention-deficit hyperactivity disorder (ADHD). It was approved in April 2021 to children 6 to 17 years of age.

“Until today, nonstimulant ADHD options for adults have been very limited,” Greg Mattingly, M.D., founding partner of St. Charles Psychiatric Associates in St. Louis, Mo., said in a press release. “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.”

Developed by Supernus Pharmaceuticals, Qelbree’s applications for adult was supported by data from positive results in a phase 3 study. That trial showed that Qelbree at a daily dose of up to 600 mg met the primary endpoint in improving the sympto ms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale.

Qelbree, novel non-stimulant treatment for children with ADHD in a decade, was launched in the second quarter of 2021 and for the year, closed the year with 13,380 prescriptions written, according to the company.

About 16 million children, adolescents, and adults have ADHD in the United States. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.