The FDA has accepted Otsuka’s New Drug Application for centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit hyperactivity disorder across all age groups.
Centanafadine is being reviewed under priority status, with a Prescription Drug User Fee Act target action date of July 24, according to a Jan. 27 news release from Otsuka. If approved, it would become the first NDSRI approved for ADHD in children, adolescents and adults.
The once-daily, extended-release capsule is supported by four phase 3 clinical trials. In those studies, the drug showed statistically significant and clinically meaningful improvement in ADHD symptoms compared to placebo, with tolerability across age groups, the release said. Common adverse events in children included decreased appetite, nausea and somnolence. In adults, the most frequent adverse events were decreased appetite and headache.
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