Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women

Core Insights - Supernus Pharmaceuticals has received FDA approval for an updated label for Qelbree, which now includes new pharmacodynamic data and lactation information [1][2][3] Group 1: Product Information - Qelbree (viloxazine extended-release capsules) is approved for treating ADHD in patients aged 6 years and older [4] - The updated label highlights viloxazine's partial agonist activity at the serotonin 5-HT2C receptor and its inhibition of the norepinephrine transporter, emphasizing its multimodal pharmacodynamic profile [1][6] - New lactation data indicates low transfer of Qelbree into breastmilk, with estimated daily infant doses of viloxazine and its metabolite being 0.085 mg/kg and 0.00595 mg/kg, respectively [2] Group 2: Clinical Insights - The updated pharmacodynamic data enhances understanding of Qelbree's effects, aiding treatment decision-making for ADHD [2][3] - The lactation study involved 15 healthy lactating women and followed a multi-dose regimen of viloxazine [2] - The study results support that the transfer of viloxazine into breastmilk is low, although it did not evaluate effects on breastfed infants [2] Group 3: Company Commitment - Supernus Pharmaceuticals aims to empower healthcare providers and patients with updated information to make informed treatment decisions [3] - The company is dedicated to building evidence around Qelbree's use in the ADHD space [3]