New Drug for Attention Problems Approved: Improvement in First Week

The FDA has approved Otsuka's drug Simtriyo (centanafadine) for treating ADHD in adults and children aged 6 and older. Taken once daily, it showed symptom improvement as early as the first week. Approval was based on four clinical trials. Side effects include rash, decreased appetite, headache, and others. The drug is not yet available in Israel.

The FDA has approved a new drug, Simtriyo (active ingredient centanafadine), developed by the Japanese company Otsuka, for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 and older weighing at least 20 kg. The drug is taken once daily as an extended-release capsule. It is the first approved ADHD medication that inhibits the reuptake of three neurotransmitters: norepinephrine, dopamine, and serotonin. The approval is based on four phase 3 clinical trials that showed significant symptom improvement compared to placebo, with improvement noted as early as the first week of therapy. The safety profile in the studies was good, but side effects were observed: in children aged 6-12, most commonly rash and decreased appetite; in older children, decreased appetite, nausea, rash, headache, and abdominal pain; in adults, headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea. Israeli Professor Iris Manor, head of the ADHD treatment department at the Geha Mental Health Center in Petah Tikva, notes that Israeli doctors have no experience with Simtriyo yet, as the drug is not available in Israel. Before the drug reaches pharmacies, the U.S. Drug Enforcement Administration (DEA) must determine its classification, which could take up to 3 months and affect availability. Simtriyo is expected to expand the market for non-stimulant ADHD medications.