Viloxaznie: FDA approves Nonstimulant for ADHD in Kids 6 -17 Years
The US Food and Drug Administration (FDA) has approved the non-stimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of (ADHD) in children aged 6 to 17 years, and adults.
Viloxazine is a selective Nor-epinephrine reuptake inhibitor. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce, as needed.
In one randomized, placebo-controlled phase 3 study that included more than 400 children, viloxazine reduced symptoms of ADHD as soon as 1 week after dosing and was well tolerated.
As reported by Medscape Medical News, the study was published last July in Clinical Therapeutics.
In addition to its fast onset of action, the fact that it was effective for both inattentive and hyperactive/impulsive clusters of symptoms is “impressive,” study investigator Andrew Cutler, MD, clinical associate professor of psychiatry, SUNY Upstate Medical University, Syracuse, New York, told Medscape Medical News.
Also noteworthy was the improvement in measures of quality of life and function, “especially function in the areas of the school, home life, family relations, and peer relationships, which can be really disrupted with ADHD.
Side effects noted were suicidal thoughts and behaviors in some children with ADHD treated with the drug, especially within the first few months of treatment or when the dose is changed. Qelbree can cause an increase in heart rate and diastolic blood pressure
Activation of Mania or Hypomania
Noradrenergic drugs, such as Qelbree, may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression.
In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with viloxazine than in patients treated with a placebo. Patients taking viloxazine should be closely monitored for any new or sudden changes in mood, behavior, thoughts, and feelings.
