Pediatric ADHD Medication Gets FDA Green Light

April 5, 2021
Leah Kuntz

This once-daily sprinkleable capsule may help patients aged 6 to 17 years with attention-deficit/hyperactivity disorder.

The US Food and Drug Administration (FDA) has approved Qelbree, viloxazine extended-release capsules created by Supernus Pharmaceuticals, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17.

“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “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.”1

Qelbree is a once-daily, rapid and extended release, sprinkleable capsule. The approval of the medication is supported by data from 4 phase 3 clinical trials that studied more than 1000 pediatric patients whose ages ranged from 6 to 17 years.

“ADHD is one of the most common mental health issues in the US,” said Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University, and Chief Medical Officer at the Neuroscience Education Institute. “The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.”1

Qelbree does carry the boxed warning of higher rates of suicidal thoughts and behaviors, which were observed in pediatric patients with ADHD during clinical trials. Qelbree-treated patients should be monitored for worsening or emergence of suicidal thoughts.2

Supernus also announced positive results from a phase III trial in adult patients with ADHD in December 2020. They plan to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

References

1. Supernus Pharmaceuticals. Supernus announces FDA approval of Qelbree™ (SPN-812) for the treatment of ADHD. News release. April 2, 2021. https://www.globenewswire.com/news-release/2021/04/02/2204030/0/en/Supernus-Announces-FDA-Approval-of-Qelbree-SPN-812-for-the-Treatment-of-ADHD.html

2. Supernus Pharmaceuticals. Highlights of prescribing information for Qelbree. https://www.supernus.com/sites/default/files/Qelbree-Prescribing-Info.pdf