Otsuka Pharmaceutical Co.has announced positive results in a phase 3b study of its oral drug, centanafadine, to reduce the symptoms of attention deficit/hyperactivity disorder (ADHD) and comorbid anxiety in adults.
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). In the clinical trial, patients with ADHD who received 280 mg of centanafadine XR daily saw a statistically-significant and clinically-relevant improvement to symptoms compared to those taking a placebo. The primary endpoint of the study was total score on the Adult Investigator Symptom Rating Scale (AISRS) at week 8 compared to baseline.
The FDA has granted centanafadine Priority Review to treat adults, adolescents, and children. It has a PDUFA target action date of July 24, 2026.