Viloxazine was approved in April by the FDA for pediatric ADHD patients between 6-17 years old.
There remains a need to develop new treatments for pediatric patients with attention deficit/hyperactivity disorder (ADHD), particularly in extended release formulation.
One such option might be viloxazine (Qelbree), which gained US Food and Drug Administration approval in April for pediatric ADHD patients between 6-17 years old.
In a double-blind study that included 297 patients 12-17 years of age who were diagnosed with ADHD, researchers found patients treated with viloxazine 400 mg treatment reached statistical significance compared to placebo in the primary endpoint, change from baseline in ADHD-RS-5 total score. Participants receiving the study drug had a -18.3 LS mean change from baseline (P = .0082) vs. LS mean change of -13.2 from baseline for those receiving placebo.
In this episode of the DocTalk Podcast, Ann C. Childress, MD, Center for Psychiatry and Behavioral Medicine, explained the promising results of viloxazine and why it could be a game changer for pediatric ADHD patients.
Childress said the extended release formulation should help reduce the social stigma for students taking medication during the school day.
However, when looking at the state of ADHD care there are some reasons to remain concerned. Childress said there is still a need to develop new treatments, particularly for pediatric patients, and there is reason to believe this patient group may have been particularly impacted by the circumstances of the COVID-19 pandemic.