Otsuka reported positive topline results from a Phase 3b study of once‑daily centanafadine XR 280 mg in adults with attention‑deficit/hyperactivity disorder (ADHD) and comorbid anxiety. The trial met its primary endpoint, showing statistically significant and clinically relevant improvements in ADHD symptoms versus placebo at week 8, as measured by change from baseline in the Adult Investigator Symptom Rating Scale (AISRS) total score. Patients treated with centanafadine achieved an LS mean change of ‑18.5 compared with ‑12.6 on placebo, for a treatment difference of ‑5.87 (p<0.0001). Statistical separation from placebo was observed as early as week 1, the first post‑baseline assessment, and was maintained throughout the 8‑week study period.
Centanafadine is a first‑in‑class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) being developed for ADHD. In addition to the primary endpoint, the study also met its key secondary efficacy endpoint, showing statistically significant improvements in anxiety symptoms. At week 8, patients in the centanafadine group had a greater reduction from baseline in Hamilton Anxiety Rating Scale (HAM‑A) total score than those on placebo (LS mean change ‑12.5 vs ‑10.6; treatment difference ‑1.92; p=0.02). Other secondary efficacy endpoints also supported the primary outcome, further characterizing the drug’s effect in adults with ADHD and co‑occurring anxiety.
The safety and tolerability profile in this study was consistent with previously reported centanafadine data and with expectations for an ADHD population with comorbid anxiety. The most frequently observed adverse events, occurring in more than 5% of centanafadine‑treated patients and more often than with placebo, included nausea, decreased appetite, diarrhea, insomnia, dry mouth and vomiting. Otsuka said the findings add to the scientific evidence supporting centanafadine’s impact on core ADHD symptoms in adults with diverse clinical presentations, including those with significant anxiety.
Centanafadine is currently under regulatory review in the United States for the treatment of ADHD in children, adolescents and adults. The U.S. Food and Drug Administration has granted the application Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026. Full results from the Phase 3b study are expected to be presented at an upcoming scientific meeting.
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