Label Update for ADHD Treatment Qelbree: New Pharmacodynamic Data and Breastfeeding Information

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The US Food and Drug Administration (FDA) has approved an update for the label for viloxazine extended-release capsules (Qelbree) to include new pharmacodynamic data and lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD).¹

In Section 12.2, the updated label details viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter. In Section 8.2, it shows the transfer of Qelbree into breastmilk is low.

Qelbree’s mechanism of action is unclear but is thought to be inhibition of the reuptake of norepinephrine. Qelbree is approved for use in patients aged 6 years and older with ADHD.

“This label update and new data deepens our understanding of Qelbree, providing valuable insights to help support treatment decision-making for people living with ADHD,” says Stephen M. Stahl, MD, PhD, DSc (Hon.) Distinguished Health Sciences Clinical Professor of Psychiatry and Neuroscience at the University of California Riverside, and adjunct professor of psychiatry at the University of California San Diego. “The updated pharmacodynamic data, which highlights viloxazine’s effects on the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, adds depth to our understanding of Qelbree’s multimodal pharmacodynamics.”

The update to include lactation data is based on a study involving 15 healthy lactating women.This follows the 2019 FDA guidance suggesting investigators conduct lactation studies to better inform recommendations for mothers who are breastfeeding with concurrent medication use.² Investigators evaluated the secretion of viloxazine and its metabolite, 5-HVLX-gluc, into breast milk following a multi-dose regimen—600 mg daily for 3 days—of viloxazine. Results showed that the estimated daily infant dose of viloxazine and 5-HVLX-gluc when using a nominal infant body weight of 6 kg was 0.085 mg/kg and 0.00595 mg/kg respectively. The relative infant dose was approximately 1% and 0.07% respectively of the weight-normalized maternal daily dose (8.58 mg/kg) of viloxazine. These data support that the transfer of viloxazine into breastmilk is low. It is important to note that the study did not specifically evaluate the effects of viloxazine on breastfed infants or milk production and there is not additional data regarding these particular effects. Clinicians, when advising breastfeeding mothers of how to proceed with medication usage, should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Qelbree, and potential adverse effects on the breastfed child from Qelbree or from the underlying condition of the mother.

“By expanding Qelbree’s label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower health care providers and patients to make informed treatment decisions,” says Jack A. Khattar, president and chief executive officer of Supernus Pharmaceuticals. “We are committed to building the body of evidence surrounding Qelbree’s use within the ADHD space and providing an effective treatment option for those living with ADHD.”

References

1. Supernus announces label update for non-stimulant ADHD treatment, Qelbree®, including new pharmacodynamic data and information for breastfeeding women. News release. January 27, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-label-update-non-stimulant-adhd-treatment

2. Clinical lactation studies: considerations for study design. Guidance for industry. US Food and Drug Administration. May 2019. Accessed January 27, 2025. https://www.fda.gov/media/124749/download