Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older

Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older

SIMTRIYO is the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for the treatment of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg

SIMTRIYO will be commercially available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA)

Approval is supported by results from four pivotal Phase 3 clinical trials in adults and pediatric patients demonstrating statistically significant and clinically meaningful improvements in ADHD symptoms and a well-characterized safety profile

ADHD is a chronic neurodevelopmental disorder that affects approximately 22.5 million children, adolescents, and adults in the U.S.