Positive topline results were announced from two phase 3 trials of centanafadine (Otsuka Pharmaceuticals) evaluating adult patients with attention-deficit hyperactivity disorder (ADHD).
Centanafadine is a serotonin-norepinephrine-dopamine reuptake inhibitor. The two, 6-week, multicenter, double-blind, placebo-controlled trials (Study 1 and Study 2) evaluated the efficacy and safety of centanafadine sustained-release tablets in approximately 900 adult patients with ADHD. Patients were randomized to receive either centanafadine 100mg or 200mg orally twice daily, or placebo. The primary end point was the change from baseline to day 42 in the adult ADHD Investigator Symptom Rating Scale (AISRS) total score.
Findings from the trials showed that both doses of centanafadine were associated with statistically significant improvements in the AISRS total score compared with placebo (P <.05 in Study 1; P <.01 in Study 2). Additionally, both trials met the secondary end point with a statistically significant improvement over placebo in the Clinical Global Impression-Severity of Illness (CGI-S) rating scale score from baseline to day 42 (P <.05).
With regard to safety, the most common adverse reactions observed with centanafadine (>5% more frequent than placebo) included decreased appetite, headache, nausea, dry mouth, upper respiratory tract infection and diarrhea.
Topline data from an ongoing, long-term safety study of centanafadine are expected in 2021. The Company also plans to assess centanafadine in pediatric patients with ADHD.
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