Overview
- The FDA accepted Otsuka’s New Drug Application for an investigational once-daily extended‑release NDSRI capsule intended for children, adolescents, and adults.
- The filing reports statistically significant improvements versus placebo measured by ADHD-RS-5 in pediatric cohorts and AISRS in adults.
- Across trials, centanafadine was generally well tolerated, with decreased appetite and headache most common in adults and abdominal pain, decreased appetite, fatigue, nausea, rash, and somnolence reported in younger patients.
- Otsuka cites clinical and preclinical data indicating favorable tolerability and low potential for abuse, with the agency’s approval decision still to come.
- If cleared, the first-in-class norepinephrine–dopamine–serotonin reuptake inhibitor could broaden non-stimulant treatment options for ADHD.