Centanafadine, a novel investigational compound for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults, demonstrated statistically significant improvements compared with placebo in a pair of 6-week, phase 3 clinical trials, announced maker Otsuka Pharmaceutical Co. Ltd. and its US subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc.
The double-blind, multicenter studies involved approximately 900 adults with ADHD randomized to receive either oral centanafadine 100 mg, centanafadine 200 mg, or placebo twice daily. In both trials, participants who received centanafadine demonstrated statistically significant improvement, compared with participants who received placebo, on the primary efficacy endpoint—change from baseline to day 42 on the adult ADHD Investigator Symptom Rating Scale total score.
Centanafadine also demonstrated statistically significant gains compared with placebo in both trials’ key secondary efficacy outcome, Clinical Global Impression–Severity scale change from baseline to day 42.
The most frequently observed side effects with centanafadine were decreased appetite, headache, nausea, dry mouth, upper respiratory tract infection, and diarrhea, according to a pooled-analysis across the 2 studies. No side effect was reported by more than 7% of patients.
Centanafadine is a serotonin-norepinephrine-dopamine triple-reuptake inhibitor. Otsuka said it plans to investigate the effects of centanafadine in children with ADHD and to discuss next steps with the US Food and Drug Administration.
Otsuka announces positive top-line results from two phase 3 studies of centanafadine for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients [press release]. Tokyo, Japan, and Princeton, New Jersey: Otsuka America Pharmaceutical, Inc.; June 11, 2020.