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FDA Approves Nonstimulant ADHD Medication Qelbree for Adult Use

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May 3, 2022The 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.

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