FDA Approves New ADHD Drug Simtriyo for Children and Adults with Early Symptom Improvement

The U.S. Food and Drug Administration (FDA) recently approved Simtriyo, a new medication developed by Japanese company Otsuka, for treating Attention Deficit Hyperactivity Disorder (ADHD) in children aged six and older weighing at least 20 kg, as well as adults. Simtriyo contains the active ingredient centanafadine and is administered once daily in a delayed-release capsule. The drug is expected to enter the U.S. market later this year after classification by the Drug Enforcement Administration (DEA), which could take up to three months.

Simtriyo is unique as it inhibits the reuptake of three neurotransmitters, norepinephrine, dopamine, and serotonin, enhancing their availability in brain pathways related to attention and behavior. This mechanism differs from existing ADHD treatments, which are mostly stimulants. Clinical approval was based on four Phase 3 trials involving children, adolescents, and adults, showing significant symptom improvement compared to placebo, with benefits observed as early as the first week of treatment. In adult studies with over 800 participants, a higher percentage achieved at least an 18-point improvement on ADHD symptom scales after six weeks. Adolescents and children receiving higher doses also showed significant symptom relief.

Reported side effects varied by age group: children experienced rash and appetite loss; adolescents reported appetite loss, nausea, rash, headache, and abdominal pain; adults most commonly had headache, appetite loss, insomnia, nausea, dry mouth, and diarrhea. Additionally, a recent Phase 3b study indicated Simtriyo’s effectiveness in patients with ADHD and coexisting anxiety.

Experts highlight that ADHD is a complex neurodevelopmental disorder affecting millions in the U.S., with symptoms impacting daily functioning. Current stimulant treatments like Ritalin are effective but have limitations, including side effects and nonresponse in 15-20% of patients. Non-stimulant options in Israel include atomoxetine and guanfacine, but Simtriyo’s broader neurotransmitter action may offer improved efficacy. Israeli specialists anticipate the drug’s potential introduction to their market following U.S. availability. The DEA’s classification will influence Simtriyo’s accessibility, with stricter scheduling possibly limiting patient access compared to other ADHD medications.