The Food and Drug Administration has approved a new ADHD medication that works differently from any drug currently on the market. The drug, called SIMTRIYO, is a daily extended-relief tablet containing the active ingredient centanafadine. It is approved for adults and children ages 6 and older who weigh at least 44 pounds.
According to Healthline, Otsuka Pharmaceutical describes SIMTRIYO as the first norepinephrine, dopamine, and serotonin reuptake inhibitor, or NDSRI, ever approved to treat ADHD. Existing ADHD medications generally target only one or two of those brain chemicals. This one targets all three.
John Kraus, MD, executive vice president and chief medical officer for Otsuka, said in a statement that "the approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition."
The company backed the drug's approval with results from four separate phase 3 clinical trials. Two involved adults between the ages of 18 and 55, given either 200 milligrams or 400 milligrams of centanafadine. A third trial enrolled 459 adolescents between the ages of 13 and 17 with a primary ADHD diagnosis. A fourth included 480 children between the ages of 6 and 12. Across all four trials, participants using SIMTRIYO demonstrated statistically significant improvements in ADHD symptoms compared to those given a placebo.
Otsuka also reported results from a phase 3b study involving adults with ADHD and comorbid anxiety. In that group, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared to placebo as well.
The most common side effects reported during the trials included decreased appetite, nausea, rash, headache, and abdominal pain in children.
Daniel Ganjian, MD, a pediatrician at Providence Saint John's Health Center in California, told Healthline he sees real potential in the new drug. "I think it will help, especially for patients have who have tried other medications without much success," he said. "It's adding more tools to our arsenal."
Before SIMTRIYO reaches pharmacy shelves, it still needs to go through hearings with the Drug Enforcement Administration to be assigned a scheduling classification. Otsuka expects the drug to be available as a prescription medication later this year.
