FDA approves non-stimulant Qelbree to treat ADHD


The US Food and Drug Administration (FDA) approves first novel non-stimulant medication to treat attention-deficit/hyperactivity disorder (ADHD) in children in a decade.

The US Food and Drug Administration has approved Qelbree (viloxazine extended-release capsules) from Supernus Pharmaceuticals, Inc. to treat attention-deficit/hyperactivity disorder aged 6 to 17 years, the first novel non-stimulant approval in a decade.1 The non-stimulant medication is taken once a day and is meant to be sprinkled into a drink or food.

The approval was given to the drug based on the results from 4 Phase III trials that included over 1000 children aged 6 to 17 years. The company is planning to submit the medication for approval in adult patients later in the year.

In a release for the approval, Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceutical, Inc., said “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research.”

Others in the medical community are more cautiously optimistic, due to some extreme side effects the medication carries. Harlan R. Gephart, MD, clinical professor of pediatrics emeritus at the University of Washington School of Medicine in Seattle and Contemporary Pediatrics editorial advisory board member responded by saying, “Overall I think it will have limited usage, mostly because of the stated safety profile. Time will tell of course but the description of possible suicidal ideation or attempt would have to be discussed with parents and patients, and might create some aversion to using it. At this point it would be for me as well…so I think Quelbee might have occasional use in a child who for some reason just can’t be given a stimulant, eg worsening tics, but otherwise will not be a first line medication.”


1. Supernus Pharmaceuticals, Inc. Supernus announces FDA approval of Qelbree™ (SPN-812) for the treatment of ADHD. Published April 2, 2021. Accessed April 5, 2021. https://www.globenewswire.com/en/news-release/2021/04/02/2204030/19871/en/Supernus-Announces-FDA-Approval-of-Qelbree-SPN-812-for-the-Treatment-of-ADHD.html

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