The Food and Drug Administration approved a new ADHD medication for adults and children as young as six, broadening treatment options for a condition affecting millions in the U.S.
Simtriyo, created by Otsuka, is an extended-release capsule that regulates three neurotransmitters: norepinephrine, dopamine, and serotonin. It blocks their reuptake, increasing norepinephrine and dopamine levels—key for focus and decision-making—while also adjusting serotonin, which helps manage emotions.
Four phase 3 clinical trials supported the approval, involving adults, adolescents, and children. In two adult studies, 744 participants received either 200 mg, 400 mg, or a placebo. Both doses of the medication led to clear improvements in ADHD symptoms, measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), within the first week. The effects lasted throughout the six-week trial.
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Trials with younger patients produced comparable outcomes. High-dose Simtriyo showed noticeable benefits on the ADHD Rating Scale-5 (ADHD-RS-5) in the first week.
Side effects differed by age. Children aged 6 to 12 most often experienced rash and reduced appetite. Adolescents aged 13 to 17 reported decreased appetite, nausea, rash, headache, and stomach pain. Adults commonly had headaches, lower appetite, insomnia, nausea, dry mouth, and diarrhea.
The drug’s labeling includes two serious warnings. One notes the risk of suicidal thoughts and behaviors in children 6 to 12. The other cautions about possible abuse and addiction, as the DEA classifies it as a controlled substance.
Otsuka plans to release Simtriyo in pharmacies later this year, once the DEA completes its scheduling process. Pricing will be announced after meeting regulatory requirements.
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ADHD impacts about 7 million children and 15.5 million adults nationwide, according to CDC data. The disorder involves ongoing inattention, hyperactivity, and impulsivity, frequently disrupting daily activities.
Lenard A. Adler, who leads the adult ADHD program at NYU Langone Health, described the approval as an important development. “ADHD varies widely, and many patients still face symptoms that interfere with their lives,” he said. “This medication offers a new approach and gives doctors and patients more choices.”
A phase 3b study found Simtriyo may help adults with ADHD and anxiety, a group representing up to half of all patients. Anxiety in this population has been tied to higher risks of suicide and hospitalization. Full findings will be shared at a future scientific conference.
