People with ADHD who don’t do well or see enough symptom improvement with existing drugs have a new treatment option: a daily pill called Simtriyo (centanafadine).
This oral medication was approved by the U.S. Food and Drug Administration to treat ADHD in children ages 6 and older, teens, and adults, according to drug company Otsuka.
Simtriyo, the first ADHD medication in its class, is a norepinephrine, dopamine, and serotonin reuptake inhibitor. It might be a better choice for some patients with ADHD, compared with commonly prescribed ADHD medications like the stimulant drug Adderall (amphetamine and dextroamphetamine), according to doctors.
“New medications for ADHD are needed because ADHD treatment still has major gaps,” says Mai Uchida, MD, a child and adult psychiatrist at Mass General Brigham and an associate professor of psychiatry at Harvard Medical School in Boston.
Clinical Trials Found Simtriyo to Be Safe and Effective
Clinical trials of Simtriyo evaluated the impact of the drug on children, teens, and adults. The most recent trial results released were for adults.
The phase 3 clinical trial investigated a 280 milligram dose of Simtriyo taken once daily for adults with ADHD and anxiety. It found that people on the medication saw statistically significant changes as early as one week in, compared with people on a placebo.
Simtriyo has also been effective in trials involving almost 500 children and about 450 teens. Participants typically reported an improvement in ADHD symptoms, with positive changes also observed by caregivers, and most tolerated the medication well. (Fewer than 8 percent dropped out of the study due to side effects.)
Each trial had slightly different results, measured by the ADHD Rating Scale–5, an 18-item questionnaire used by doctors, parents, and teachers to diagnose and evaluate ADHD in children and teens.
Simtriyo Side Effects Are Similar to Other ADHD Medications
Potential Simitriyo side effects that emerged in clinical trials include the following:
- Decreased appetite
- Nausea
- Headache
- Rash
Most side effects were mild or moderate.
Who Should Take Simtriyo? Who Shouldn’t?
Some patients don’t respond well to the existing battery of ADHD medications, and Simtriyo could simply provide another option.
With certain stimulant ADHD medications, “Some people have intolerable side effects, anxiety, appetite, or sleep problems, cardiovascular concerns, or concerns about misuse or diversion,” says Dr. Uchida.
Simtriyo may also be of interest for patients with ADHD and co-occurring anxiety, she notes.
Children who struggle to gain weight while taking certain stimulant ADHD medication may benefit from Simtriyo too, according to Neha Sharma, DO, chief of child and adolescent psychiatry at Tufts Medical Center in Boston.
But Simtriyo may not be for everyone. “It is possible that this medication may be too activating for some children with anxiety,” Dr. Sharma says. It also is unlikely to be a good fit for children who can’t tolerate selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, or bupropion, she says.
How Simtriyo Works
Simtriyo enhances the activity of natural chemical messengers in the brain that impact behavior, says Kelly Johnson-Arbor, MD, a toxicologist at MedStar Health in Washington, DC.
“Stimulants primarily affect dopamine and norepinephrine activity, while nonstimulants typically affect norepinephrine,” she says. “Centanafadine affects three different chemical messengers in the brain: dopamine, norepinephrine, and serotonin.”
Simtriyo’s unique serotonin-targeting effects may be particularly important, according to Dr. Johnson-Arbor. “There is emerging evidence suggesting that serotonin affects many central nervous system functions, including emotional regulation, attention, and impulsivity,” she says. “Because of this, medications like centanafadine, which target serotonin, may be beneficial for some patients with ADHD.”
Simtriyo Will Be Available Later This Year
Otsuka has not given a release date for the medication. However, it’s expected to be available to the public before the end of the year. As of now, pricing is unclear.
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