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 (PDUFA) 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.
Researchers assessed symptom improvements in children and adolescents using the ADHD Rating Scale-5. For adults, they relied on the ADHD Investigator Symptom Rating Scale. Across trials, trial participants tolerated the drug well. The most commonly reported side effects included decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in younger patients, and decreased appetite and headache in adults.
“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available,” said Otsuka Pharmaceutical Development & Commercialization executive vice president and chief medical officer John Kraus, MD, PhD, said.
He called the FDA’s acceptance and priority review designation “an important milestone” and stressed the company’s goal to expand treatment options for people living with ADHD.
Priority review accelerates the FDA’s standard review timeline. In short, it hints that the agency considers the application to have the potential to dramatically boost “the treatment, diagnosis, or prevention of a serious condition.”
Otsuka execs also point out that the clinical and preclinical data suggest centanafadine could present a low abuse risk. And that’s critical, considering the stimulant properties of so many ADHD treatment options.
Further Reading
ADHD Drugs Don’t Sharpen Attention. They Increase Drive.
Management of Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder
