FDA Updates Viloxazine Label for ADHD

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The FDA approved an updated label for viloxazine extended-release capsules (Qelbree; Supernus Pharmaceuticals Inc.) to include new pharmacodynamic data, furthering the understanding of the drug for individuals with attention-deficit/hyperactivity disorder (ADHD). Viloxazine is approved for patients 6 and older.¹

The new label includes updated information on the use of the drug for individuals who are lactating and breastfeeding. | Image Credit: Postmodern Studio | stock.adobe.com

“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,” Stephen M. Stahl, MD, PhD, DSc (Hon), distinguished health sciences clinical professor of psychiatry and neuroscience at the University of California Riverside, said in a news release. “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.”¹

The updated label states, “Viloxazine binds to and inhibits the norepinephrine transporter (Ki = 0.13 μM). In addition, viloxazine binds to and exhibits partial agonist activity at the serotonin 5-HT2C receptor (Ki = 0.66 μM),” but the exact mechanism of action is still unknown, according to the news release.^1,2

Additionally, the updated label includes new data on lactation for individuals who are breastfeeding, showing that the transfer of the drug into breast milk is low. The data come from a study involving 15 healthy women who were lactating. Investigators evaluated the secretion of the drug and its metabolite, 5-HVLX-gluc, into breast milk following a regimen of 600 mg daily doses for 3 days of the drug.¹

They found that the estimated infant dose of the drug and the metabolite were 0.085 mg/kg and 0.00595 mg/kg, respectively, with the relevant infant dose using an infant body weight of 6 kg being 1% and 0.07%, respectively, with the maternal daily dose of the drug. The investigators did not specifically evaluate the effects of the drug on breastfed infants or milk production, so there is no additional data for these effects, according to the news release. The developmental and health benefits of breastfeeding should be considered for use of the drug for this patient population, along with the individual’s clinical need for the drug and potential adverse effects on the breastfed infant due to the drug.¹

The efficacy of the drug for pediatric patients was evaluated in 3 short-term studies (NCT03247530; NCT03247543; NCT03247517) for pediatric patients and 1 study (NCT04016779) for adult patients. For the pediatric studies, investigators found that the ADHD Rating Scale scores were statistically significant for patients treated with viloxazine compared with the placebo. In study 1, investigators randomized treatment as 100 mg or 200 mg viloxazine or the placebo, and study 2 and study 3 included 200 mg, 400 mg, or the placebo. There was also a greater reduction for the Clinical Global Impression-Improvement score for all 3 studies across all treatment arms compared with the placebo, according to the clinical trial information.²

As for the adult patient study, individuals started at the 200 mg dose and titrating up to 400 mg once daily for week 2. The dose was adjusted to 200 mg per day once weekly for a minimum of 200 mg as the daily dose and a maximum of 600 mg once daily. They found that the change from baseline in the AHDH Investigator Symptom Rating Scale was statistically greater for adults who were treated with the drug compared with the placebo. Further, the clinical global impression-severity of illness score was also statistically greater for adults being treated with viloxazine compared with the placebo.²

REFERENCES

1. Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree, Including New Pharmacodynamic Data and Information for Breastfeeding Women. News release. Supernus Pharmaceuticals. January 27, 2024. Accessed January 27, 2024. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-label-update-non-stimulant-adhd-treatment

2. Qelbree: prescribing information. Supernus Pharmaceuticals. Accessed January 27, 2025. https://www.supernus.com/sites/default/files/Qelbree-Prescribing-Info.pdf