FDA Approves Nonstimulant ADHD Medication Qelbree for Adult Use
The first nonstimulant ADHD medication approved by the FDA for adult use in two decades, Qelbree (Viloxazine) achieved positive results in a randomized, double-blind, placebo-controlled Phase 3 study.
May 3, 2022
The first nonstimulant ADHD medication for adults introduced in two decades, Qelbree was approved last week by the U.S. Food & Drug Administration (FDA) for use in patients aged 18 to 65. Qelbree (viloxazine) is an extended-release capsule taken once a day that showed no evidence of abuse potential in clinical studies. FDA approval followed review of a randomized, double-blind, placebo-controlled Phase III study of Qelbree in adults with ADHD that showed “efficacy and symptom improvement” early in treatment, according to the drug manufacturer Supernus Pharmaceuticals. (Qelbree received FDA approval for the treatment of ADHD in children ages 6 to 17 in April 2021.)
“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, M.D., founding partner of St. Charles Psychiatric Associates, in a statement. “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.
Supernus said in a press release that Qelbree “has a proven safety and tolerability profile,” as demonstrated in its Phase III trial, which administered a daily flexible-dose of 200 mg to 600 mg and measured outcomes based on the Adult ADHD Investigator Symptom Rating Scale (AISRS). Supernus has not yet announced when Qelbree will be available to adult patients in the United States.
The once-daily, flexible-dose nonstimulant ADHD drug medication belongs to the selective norepinephrine reuptake inhibitor (SNRI) group of medicines. Safety information may be found at qelbree.com.