FDA Approves Centanafadine for Attention-Deficit/Hyperactivity Disorder in Patients Aged 6 and Older

The U.S. Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO; Otsuka), a novel once-daily extended-release capsule, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults aged 6 years and older. Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). The approval is based on four pivotal Phase 3 trials, with high-dose centanafadine demonstrating significant improvement in ADHD symptoms as early as week 1 in pediatric and adolescent trials.