Approvals

The Food and Drug Administration (FDA) on July 24 approved centanafadine, a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and in children aged 6 and older weighing at least 20 kg. Marketed by Otsuka Pharmaceutical as SIMTRIYO, the triple-acting agent resulted in significant and clinically meaningful improvement in ADHD symptoms compared with placebo in four Phase 3 trials. For both adults and children, symptom improvement was seen as early as the first week of treatment. The most common adverse events in adults and children included decreased appetite, headache, and nausea. Product labeling for SIMTRIYO will include a warning regarding suicidal ideation and behaviors in pediatric patients, who experienced higher rates of suicidality in clinical trials. Centanafadine is expected to be available by the end of this year. [https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine]