Otsuka Pharmaceuticals announced positive results from 2 Phase 3 clinical trials evaluating the efficacy, safety and tolerability of centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor , for the treatment of adolescents and children suffering from attention deficit/hyperactivity disorder. disorder (ADHD).1
“Otsuka is committed to finding new solutions to address complex and undermet medical needs,” said John Kraus, MD, PhD, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization. “We are pleased that these pivotal Phase 3 results demonstrate that centanafadine has the potential to offer a new treatment option for children and adolescents with ADHD, a condition that can affect all aspects of life.
The first trial (NCT05257265) evaluated the efficacy, safety, and tolerability of centanafadine in adolescents aged 13 to 17 years with ADHD, while the second trial (NCT05428033) evaluated centanafadine in older children 6 to 12 years old with ADHD. The primary endpoint of both trials was change from baseline to week 6 in the ADHD Rating Scale total symptom score (ADHD-RS-5), and both trials had this. reached. Both trials were 6-week, 3-arm, double-blind, fixed-dose trials in which participants were randomized to low-dose centanafadine, high-dose centanafadine, or placebo; the dose was determined based on body weight.
In the first trial, participants receiving centanafadine saw statistically significant improvements compared to placebo for the mean high- and low-dose effect ((p=0.0099)) and for the high-dose groups ((p=0.0099)). (p = 0.0006)). In the second trial, participants receiving centanafadine saw statistically significant improvements compared to placebo for the mean high- and low-dose effect ((p=0.0039)) and for the centanafadine-treated group at the highest dose high ((p = 0.0008)). The low-dose centanafadine groups in both trials did not reach statistical significance; however, the high-dose centanafadine group showed improvement over placebo as early as week 1.
In both studies, the most common side effects of centanafadine included decreased appetite, nausea, rash, fatigue, upper abdominal pain, and drowsiness.
Reference
1. Otsuka Pharmaceutical announces positive top-line results from two pivotal Phase 3 trials of centanafadine as a treatment for adolescents and children with attention-deficit/hyperactivity disorder (ADHD). Otsuka. Press release. October 27, 2023. https://otsuka-us.com/news/otsuka-pharmaceutical-announces-positive-topline-results-two-pivotal-phase-3-trials
