FDA Approves New ADHD Treatment Option for Children
The US Food and Drug Administration (FDA) has approved a selective norepinephrine reuptake inhibitor, viloxazine, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 to 17 years.1
The nonstimulant treatment option was associated with greater improvement of ADHD symptom severity when compared with placebo in 4 Phase III clinical trials involving 1019 pediatric patients.
The drug carries a warning of potential suicidal ideation, which occurred in 9 of the 1019 study participants.2
Viloxazine is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs), as it may increase risk of hypertensive crisis.2
The manufacturer, Supernus Pharmaceuticals, hopes to obtain FDA approval for this treatment option for use in adults with ADHD in the coming months.
—Leigh Precopio
References:
- Supernus announces FDA approval of Qelbree (SPN-812) for the treatment of ADHD. News release. Supernus Pharmaceuticals; April 2, 2021. Accessed April 7, 2021. https://ir.supernus.com/node/12206/pdf
- Supernus Pharmaceuticals, Inc. Qelbree highlights of prescribing information. Accessed April 7, 2021. https://www.supernus.com/sites/default/files/Qelbree-Prescribing-Info.pdf