Otsuka’s drug eases symptom burden, anxiety in ADHD as FDA verdict nears

Otsuka's investigational ADHD drug centanafadine significantly reduced overall symptom burden and anxiety in adults with ADHD and comorbid anxiety in a Phase 3b study, with a 5.87‑point improvement on ADHD symptoms and a 1.92‑point advantage on anxiety scales versus placebo at week 8.

The drug is currently under Priority Review by the FDA for ADHD in children, adolescents, and adults, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.

Topline results from this anxiety‑focused trial were not part of Otsuka’s regulatory submission but are intended to bolster the scientific and clinical case for the drug as the FDA decision nears.