Viloxazine extended-release capsules (viloxazine ER, Qelbree™) is a novel non-stimulant, recently approved by the U.S. FDA for the treatment of ADHD in pediatrics. Here, we characterize the pharmacokinetics (PK) of viloxazine and its major metabolite 5-HVLX-gluc using a population PK model, and evaluate the impact of 1-4 days of missed viloxazine ER doses on viloxazine PK. Data from four phase 3 trials in pediatric subjects treated with viloxazine ER were used to establish the PK model….
