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FDA Approves SIMTRIYO for ADHD in Adults and Children
2 Aug
Summary
- New ADHD medication SIMTRIYO receives FDA approval.
- It's the first NDSRI drug for treating ADHD.
- Available later this year for ages 6 and up.
The U.S. Food and Drug Administration (FDA) has granted approval for SIMTRIYO, a new medication designed to treat attention deficit hyperactivity disorder (ADHD). This daily extended-relief tablet, which contains the active ingredient centanafadine, is a novel treatment approach as it is the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) to target ADHD.
SIMTRIYO is approved for use in both adults and children aged 6 and older who weigh at least 44 pounds. Otsuka Pharmaceutical, the developer, reports that clinical trials involving adults, adolescents, and children showed statistically significant and clinically meaningful improvements in ADHD symptoms compared to placebo.
The medication is anticipated to be available by prescription later in 2026, following its scheduling classification by the federal Drug Enforcement Administration (DEA). While clinical trials indicated effectiveness, the drug carries a boxed warning regarding potential risks such as suicidal ideation and behaviors in pediatric patients, as well as the potential for abuse, misuse, and addiction.
Experts view SIMTRIYO as a valuable addition to the treatment arsenal for ADHD, particularly for patients who have not found success with other medications. Its unique mechanism of action on multiple neurotransmitters offers a new therapeutic option. ADHD affects an estimated 7 million children and 15 million adults in the United States, and individualized treatment plans involving therapy and medication are crucial.
