The US FDA has approved centanafadine (simtriyo) extended-release capsules, a norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) and central nervous system stimulant, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg. Mechanism of Action Centanafadine inhibits the reuptake of norepinephrine, dopamine, and serotonin, increasing the availability of these neurotransmitters in the central nervous system. Clinical Evidence The approval was based on randomized, placebo-controlled clinical trials in pediatric patients aged 6 to 12 years, adolescents aged 13 to 17 years, and adults with ADHD.
Compared with placebo, centanafadine improved ADHD-RS-5 Total scores in children aged 6 to 12 years (-16.3 vs -10.8) and adolescents aged 13 to 17 years (-18.5 vs -14.2). In adults, efficacy was…
