Otsuka files for US approval for centanafadine in ADHD

Japanese drugmaker Otsuka (TYO: 4578) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for centanafadine, an investigational compound for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

Centanafadine, once-daily extended-release capsules, is an investigational first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) that demonstrated statistically significant and clinically meaningful improvements in core ADHD symptoms across four pivotal Phase III trials. The investigational therapy showed a favorable safety and tolerability profile and a low potential for abuse and dependence.

The company noted that ADHD affects about 7 million children and 15.5 million adults in the USA. Despite current treatments, there remains a need for additional options that effectively manage symptoms across age groups.