Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., have unveiled encouraging outcomes from two Phase 3 clinical trials assessing the efficacy of centanafadine, an investigational compound designed to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. These trials exhibited statistically significant improvements compared to the placebo for the primary efficacy endpoint. ADHD, affecting an estimated six million U.S. children and adolescents, was the focus of two pivotal trials (NCT05257265 for ages 13-17 and NCT05428033 for ages 6-12), both employing a three-arm, double-blind, fixed-dose methodology. Results indicated significant symptom alleviation in adolescents and children treated with centanafadine. The drug's safety profile aligned with broader clinical development findings, revealing side effects such as decreased appetite and fatigue. Ongoing clinical pharmacology and stability studies are paving the way for a U.S. New Drug Application filing. Centanafadine, a first-in-class reuptake inhibitor, presents a potential breakthrough for ADHD treatment in various age groups, building on positive Phase 3 outcomes in adult patients. The trials utilized the ADHD Rating Scale (ADHD-RS-5) to evaluate symptom severity, and Otsuka expresses gratitude to all involved parties, with plans to publish comprehensive results in scientific journals.
> > Otsuka Pharmaceutical Press Release