Otsuka sees success in two phase 3 trials of centanafadine to treat ADHD

Otsuka Pharmaceutical has announced positive outcomes from two 6-week phase 3 clinical trials testing the safety and efficacy of centanafadine for the treatment of ADHD, according to a press release.

Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibitor, which was tested in children aged 6 to 12 years in one trial and adolescents aged 13 to 17 years in the other, Otsuka said in the press release.

Both trials were randomized, double-blind, fixed dose trials where patients received either high-dose centanafadine, low-dose centanafadine or placebo over the course of 6 weeks. According to the release, researchers found “statistically significant” improvements compared with placebo for the high-dose groups and the average effect of the high- and low-dose groups. The effect on low-dose groups was not statistically significant.

The most frequent side effects were decreased appetite, nausea, rash, fatigue, upper abdominal pain and somnolence.

The trial results will be submitted for scientific publication at a later date, Otsuka said in the release. The company is currently working on clinical pharmacology and long-term stability studies.

“Otsuka is committed to finding novel solutions for complex, underserved medical needs,” John Kraus, MD, PhD, executive vice president and chief medical officer for Otsuka Pharmaceutical development and commercialization, said in the release. “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.”