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FDA Approves Nonstimulant Medication for ADHD in Children 6 Years and Above

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eMediNexus    06 April 2021

The US Food and Drug Administration (FDA) has granted approval for the nonstimulant medication viloxazine extended-release capsules to treat attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age.

The drug is a selective norepinephrine reuptake inhibitor. The approval comes after promising data from four phase 3 clinical trials that included over 1000 children aged 6 to 17 years. One of the randomized, placebo-controlled trial included more than 400 children, and noted that viloxazine decreased ADHD symptoms as early as 1 week following dosing and the drug was well tolerated. The drug has a fast onset of action, and has been found to be effective for inattentive as well as hyperactive/impulsive clusters of symptoms… (Medscape)

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