Evaluating the Impact of Caffeine on the Incidence of Adverse Events During Treatment with Viloxazine Extended-Release (Qelbree®) in Adults with ADHD

Abstract Introduction Viloxazine ER (viloxazine extended-release capsules (Qelbree ® ) is a novel, nonstimulant, FDA-approved treatment for attention-deficit/hyperactivity disorder (ADHD) in adults and children ≥6 years of age. inhibits cytochrome P450-1A2, the enzyme responsible caffeine metabolism. In Phase 1 study, peak exposure (C max was unchanged, while systemic total (AUC) shown to increase ~5-fold following coadministration (200mg) with viloxazine (900 mg/day x 4 days) compared alone. Except insomnia (44.4%), possibly dizziness (8.3%), incidence adverse events (AEs) not notably higher vs. either or The objective this analysis evaluate impact consumption on AEs ADHD treated ER. Methods Data were analyzed from 3, double-blind (DB), placebo-controlled trial (NCT04016779) ensuing (ongoing) open-label extension (OLE) safety (NCT04143217) supporting indication ADHD. Participants reported intake during past week at each study visit. Correlation assessed between dose (mg/day) weekly (mg) Investigator Symptom Rating Scale (AISRS) Total score consumption. Fifteen AE preferred terms, known be associated consumption, evaluated. For ER-treated subjects (200–600 mg/day) who experienced potentially caffeine-associated AE, probability occurred as function DB OLE trials estimated using logistic regression model an ≥5%. Results Of 372 enrolled ~85% use trial; mean 1034 mg/week placebo group 859 group. There no correlation (p=0.73), nor AISRS (p=0.908). reporting use, 44 (DB placebo), 79 ER), 33 (OLE ER) any pre-identified caffeine- included analysis. these subjects, insomnia-related AEs, fatigue, nausea, headache-related decreased appetite, somnolence-related ≥5% subjects. Based analysis, significantly increased experiencing only (p=0.02). Conclusions This suggests concomitantly does likelihood caffeine-related except insomnia. Still patients should aware potential augment exposure. Funding Supernus Pharmaceuticals, Inc.