Supernus: FDA Approves Qelbree Label Update with New Data & Guidance

Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of CNS diseases, announced that the US Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2.

The updated label describes viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low. Qelbree is approved for use in patients ages 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 Dr. Stephen M. Stahl, M.D., PhD, DSc (Hon.) Distinguished Health Sciences Clinical Professor of Psychiatry and Neuroscience, University of California Riverside and Adjunct Professor of Psychiatry, 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 in the label (Section 8.2) follows the 2019 FDA guidance suggesting lactation studies be conducted to inform breastfeeding with drug use recommendations and is based on a study involving 15 healthy lactating women. The study evaluated the secretion of viloxazine and its metabolite (5-HVLX-gluc) into breast milk following a multi-dose (600 mg daily for three days) regimen of viloxazine. Results showed that the estimated daily infant dose (using a nominal infant body weight of 6 kg) of viloxazine and 5-HVLX-gluc was 0.085 mg/kg and 0.00595 mg/kg, respectively, and 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. The study did not specifically evaluate the effects of viloxazine on breastfed infants or milk production, nor is there additional data regarding these effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qelbree and any potential adverse effects on the breastfed child from Qelbree or from the underlying maternal condition.

“By expanding Qelbree’s label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower healthcare 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.”

Qelbree (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

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