Shots:
- Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder
- The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the study. Significant benefits were also observed in the key 2EPs, incl. HAM-A score (-12.5 vs -10.6)
- Full results to be presented at a future meeting. Additionally, Centanafadine is under FDA Priority Review for ADHD in children, adolescents, & adults, with a PDUFA target action date of Jul 24, 2026
Ref: Otsuka | Image: Otsuka | Press Release
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