The FDA has approved centanafadine as a first-in-class treatment for ADHD in both adult and pediatric patients.
The FDA has approved centanafadine, a first-in-class treatment for attention-deficit/hyperactivity disorder (ADHD), for use in adults and children aged 6 years and older. This once-daily extended-release capsule is the only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for this indication. Lenard A. Adler, MD, a co-investigator and director of the adult ADHD program at NYU Langone Health, stated that the approval introduces a novel mechanism of action and expands the range of options for patients. The medication was approved based on positive results from four phase 3 trials showing significant clinical improvement in ADHD symptoms across various patient populations. While the drug was considered well- tolerated across all trials, common side effects included headache, decreased appetite, and insomnia. The medication is expected to be released later this year following US Drug Enforcement Administration scheduling.