New ADHD treatment receives FDA fast track designation

Otsuka Pharmaceutical has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application for centanafadine for priority review. The pharma giant developed the drug to treat attention‐deficit/hyperactivity disorder (ADHD) and could emerge as the first approved therapy in a new pharmacologic class. The agency has set a Prescription Drug User Fee Act target action date of July 24, 2026. Centanafadine is a once‐daily, extended‐release capsule designed to curb the reuptake of a trio of crucial neurotransmitters —norepinephrine, dopamine and serotonin. If regulators sign off on the drug, it would be the first ADHD drug to incorporate all three mechanisms. Four Phase 3 clinical trials evaluated centanafadine across pediatric, adolescent and adult populations and appear to support the company's case. In those studies, the drug met its primary efficacy endpoints. It also produced statistically significant and clinically meaningful reductions in ADHD symptoms.