FDA Approves Label Update for Viloxazine Capsules to Include New Lactation Data

Credit: FDA

Supernus Pharmaceuticals announced on January 27, 2025, that the US Food and Drug Administration (FDA) approved an update for the label for viloxazine extended-release capsules (Quelbree) to include new lactation data for breastfeeding with ADHD, stating the low likelihood of the medication transferring into breastmilk. The updated label also now describes the medication’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter.

“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,” said Stephen M. Stahl, MD, PhD, health sciences clinical professor of psychiatry and neuroscience at the University of California Riverside and adjunct professor of Psychiatry of University of California San Diego, in a statement. “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 FDA approved viloxazine extended-release capsules as an ADHD treatment for children aged 6 – 17 years on April 2, 2021 and for adults aged ≥ 18 years on May 1, 2022.2,3 This medication may increase blood pressure and heart rate, cause manic episodes in patients with bipolar disorder, and lead to adverse events of sleepiness, not feeling hungry, tiredness, nausea, vomiting, trouble sleep, irritability, insomnia, headache, dry mouth, and constipation.

The updated label follows the FDA’s suggestion in 2019 to conduct lactation studies to inform breastfeeding with drug use recommendations. A study evaluated the secretion of 600 mg daily viloxazine and its metabolite (5-HVLX-gluc) into breast milk among 15 healthy lactating women.

The study found the estimated daily infant dose of viloxazine and 5-HVLX-gluc for 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% for viloxazine and 0.07% for 5-HVLX-gluc of the weight-normalized maternal daily dose of 8.58 mg/kg viloxazine. The results suggest that the transfer of viloxazine into breastmilk is low; however, the study did not specifically assess the effects of viloxazine on breastfed infants or milk production.

Supernus Pharmaceuticals recognized the need to consider the developmental and health benefits of breastfeeding, especially in terms of the mother’s need for viloxazine and any potential adverse events on the breastfed child.

“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,” said Jack A. Khattar, president and chief executive officer of Supernus Pharmaceuticals, in the press release. “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. Supernus Pharmaceuticals. January 27, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-label-update-non-stimulant-adhd-treatment. Accessed January 27, 2025.}
2. ^{Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD. Supernus Pharmaceuticals. April 2, 2021. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreetm-spn-812-treatment-adhd. Accessed January 27, 2025.}
3. ^{Kunzmann, K. FDA Approves Viloxazine Capsules for Adults with ADHD. HCPLive. May 1, 2022. https://www.hcplive.com/view/fda-approves-viloxazine-capsules-adults-adhd. Accessed January 27, 2025.}