The Food and Drug Administration (FDA) has approved the Qelbree® (viloxazine extended-release) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults 18 years of age and older. Previously, the nonstimulant ADHD agent was only approved for patients 6 to 17 years of age.
Qelbree is a selective norepinephrine reuptake inhibitor. The approval was based on data from a randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04016779), which assessed the efficacy and safety of viloxazine in adults 18 to 65 years of age with ADHD. The trial included a 2-arm flexible dose design in which patients were randomly assigned to receive a daily dose of viloxazine (200 mg to 600 mg; n=175) or placebo (n=179).
Results showed that the change from baseline (reduction) in the ADHD Investigator Symptom Rating Scale Total score was statistically significantly greater in adults treated with viloxazine than in adults on placebo (-15.5 point change vs -11.7 point change, respectively; P =.004). Treatment with viloxazine was also associated with statistically significant improvement vs placebo on the Clinical Global Impression – Severity of Illness Scale at week 6 (P =.0023). The average viloxazine dose at the end of the study was 504 mg per day.
The most common adverse reactions reported were insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth and constipation.
Qelbree carries a Boxed Warning regarding the risk of suicidal thoughts and behavior. Among 189 Qelbree-treated adults, a total of 3 patients reported suicidal ideation vs 0 of 183 adults who received placebo. Suicidal behavior was not reported in either treatment arm in the adult study. Before starting treatment, patients should be screened for a personal or family history of suicide, bipolar disorder, and depression.
Qelbree is supplied as 100 mg, 150 mg, or 200 mg extended-release capsules in 30-, 60-, 90-, and 100-count bottles. Capsules may be swallowed whole or opened and the contents mixed with applesauce or pudding.
- Supernus announces FDA approval of Qelbree® for the treatment of ADHD in adults. News release. Supernus Pharmaceuticals, Inc. April 29, 2022. Accessed May 2, 2022. https://www.globenewswire.com/news-release/2022/04/30/2433003/19871/en/Supernus-Announces-FDA-Approval-of-Qelbree-for-the-Treatment-of-ADHD-in-Adults.html
- Qelbree. Package insert. Supernus Pharmaceuticals, Inc.; 2022. Accessed May 2, 2022. https://www.supernus.com/sites/default/files/Qelbree-Prescribing-Info.pdf
This article originally appeared on MPR