The FDA approved Simtriyo (centanafadine), making it the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20 kilograms, according to a July 24 news release from Otsuka Pharmaceutical.
Here are four things to know.
- The drug introduces a new mechanism of action. According to Otsuka, Simtriyo works by inhibiting the reuptake of norepinephrine, dopamine and serotonin, increasing the availability of these neurotransmitters in pathways involved in attention and behavioral regulation.
- The FDA decision was supported by four phase 3 trials. The approval was based on four pivotal phase 3 clinical trials in adults, adolescents and children. The studies showed statistically significant improvements in ADHD symptoms compared with placebo, with improvements observed as early as week one.
- Commercial launch will follow Drug Enforcement Administration scheduling. Otsuka said Simtriyo is expected to become available later this year after scheduling by the DEA.
- Additional research is ongoing. The company said a recently completed phase 3b study in adults with ADHD and comorbid anxiety also met its primary endpoint, with full results to be presented at an upcoming scientific meeting.
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