Otsuka Pharmaceutical Companies (U.S.) and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. today announced positive results of two, 6-week, Phase 3 clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD).
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor.
The first trial (NCT05257265) was a pivotal Phase 3, 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.
The second trial (NCT05428033) was a pivotal Phase 3, randomized, double-blind, 3-arm, fixed-dose trial to evaluate the efficacy, safety, and tolerability of centanafadine for children with ADHD from the ages of 6 to 12 years.
The trials were similar in design; both were three-arm, double-blind, fixed-dose trials in which patients were randomized to receive either low-dose centanafadine, high-dose centanafadine, or placebo.
“Otsuka is committed to finding novel solutions for complex, underserved medical needs,” said John Kraus, M.D., Ph.D., EVP and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We are pleased these pivotal Phase 3 results demonstrate centanafadine has the potential to offer a new treatment option for children and adolescents who live with ADHD, a condition that can affect every aspect of life.”
