Positive top-line Phase III results for Otsuka's ADHD candidate

Japanese drugmaker Otsuka (TYO: 4578) today announced positive results of two, six-week, Phase III clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD).

Otsuka says that its centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor. The Japanese firm gained rights to the compound along with its acquisition of privately-held US firm Neurovance in 2017, for which it paid $100 million upfront with $150 million contingent on developmental milestones.

The first trial (NCT05257265) was a pivotal Phase III, randomized, double-blind, three-arm, fixed-dose trial to evaluate the efficacy, safety, and tolerability of centanafadine for adolescents with ADHD from the ages of 13 to 17 years.