US FDA Approves Otsuka's Simtriyo for ADHD

The U.S. Food and Drug Administration has granted approval to Simtriyo (centanafidine), Otsuka Pharmaceutical’s first‑in‑class norepinephrine, dopamine and serotonin reuptake inhibitor, for the treatment of attention‑deficit hyperactivity disorder (ADHD). The once‑daily extended‑release capsule is authorized for adults and pediatric patients aged six years and older who weigh at least 20 kg. Approval was based on four pivotal Phase III trials that demonstrated statistically significant reductions in ADHD symptoms measured by the ADHD Rating Scale‑5 and the Adult ADHD Investigator Symptom Rating Scale, with improvements observable as early as the first week of treatment. Simtriyo was generally well tolerated; the most common adverse reactions reported were decreased appetite and rash. The drug will become available later this year after scheduling by the U.S. Drug Enforcement Administration.