FDA Approves Simtriyo, a New ADHD Medication for Adults and Children Aged 6 and Older
The U.S. Food and Drug Administration (FDA) has approved Simtriyo (centanafadine), a new once-daily extended-release capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children aged 6 and older. Simtriyo is classified as a central nervous system stimulant but operates differently from traditional ADHD stimulants by acting on three neurotransmitters: dopamine, norepinephrine, and serotonin. Traditional stimulants primarily target dopamine and norepinephrine, while serotonin is involved in mood and emotional processing. Clinical trials demonstrated that Simtriyo improved core ADHD symptoms, though it has not been directly compared to other ADHD medications. The drug's manufacturer, Otsuka, suggests Simtriyo may help with emotional dysregulation and executive function, benefits that were observed in exploratory post hoc analyses of trial data. Simtriyo is not yet commercially available as it awaits controlled substance scheduling by the U.S. Drug Enforcement Administrat...