New ADHD Drug Gets Approval
People with attention-deficit/hyperactivity disorder who haven’t found relief with existing medications now have a new option: Simtriyo, a daily pill approved by the U.S. Food and Drug Administration for children as young as six, teens, and adults.
The drug, developed by Otsuka, is a norepinephrine, dopamine, and serotonin reuptake inhibitor. Unlike stimulants such as Adderall, which primarily target dopamine and norepinephrine, Simtriyo affects three key neurotransmitters, potentially offering a different approach for patients who don’t respond well to current treatments.
Clinical trials show early promise
A phase 3 trial in adults with ADHD and anxiety found that those taking a 280-milligram dose of Simtriyo saw statistically significant improvements in symptoms within a week, compared to a placebo. Similar results emerged in studies involving nearly 500 children and 450 teens, with most participants tolerating the drug well.
In one trial of children ages 6 to 12, 34% of those on a high dose of Simtriyo achieved at least an 18-point reduction on the ADHD Rating Scale-5, a standard diagnostic tool. Only 23% of the placebo group saw the same improvement. The pattern held for teens, though the exact numbers varied slightly between studies.
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Fewer than 8% of participants dropped out due to side effects, which included decreased appetite, nausea, headache, and rash—most of them mild or moderate.
Who might benefit—and who might not
For some patients, Simtriyo could fill a gap in ADHD treatment. Mai Uchida, a child and adult psychiatrist at Mass General Brigham and associate professor at Harvard Medical School, notes that existing medications can cause intolerable side effects, from anxiety and sleep problems to cardiovascular concerns. Stimulants, in particular, carry risks of misuse or diversion.
The drug may also appeal to patients with co-occurring anxiety, though its effects on that condition weren’t the primary focus of trials. Neha Sharma, chief of child and adolescent psychiatry at Tufts Medical Center, suggests it could be an option for children who struggle to gain weight on stimulants. But she cautions that it might not suit everyone—especially those who can’t tolerate other medications targeting serotonin or norepinephrine.
“It is possible that this medication may be too activating for some children with anxiety,” Sharma said.
How it works—and when it will be available
Simtriyo enhances the activity of dopamine, norepinephrine, and serotonin—chemical messengers that influence behavior, focus, and emotional regulation. Kelly Johnson-Arbor, a toxicologist at MedStar Health, points to emerging evidence that serotonin plays a role in attention and impulsivity, which could explain why targeting it alongside the other two neurotransmitters might help some patients.
“Stimulants primarily affect dopamine and norepinephrine, while nonstimulants typically target norepinephrine alone,” Johnson-Arbor said. “Centanafadine’s effect on serotonin may offer benefits for patients who haven’t responded to other options.”
Otsuka hasn’t announced a specific release date.
