Otsuka Pharmaceutical announced that the FDA has accepted for priority review the New Drug Application (NDA) for centanafadine, an investigational, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.
The NDA is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations1,2,3. In these trials, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale – 5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Centanafadine was generally well tolerated across studies, with the most common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults.
“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “The FDA’s acceptance and priority review designation of our NDA for centanafadine marks an important milestone in our effort to bring forward a novel treatment option for people living with ADHD. If approved, centanafadine would offer a first-in-class NDSRI option designed to support broad symptom management. We extend our sincere gratitude to the patients, caregivers, and investigators whose participation made this milestone possible.”
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!