FDA Approves First NDSRI for ADHD in Adults and Children

The U.S. Food and Drug Administration has approved centanafadine, marketed as Simtriyo by Otsuka, for the treatment of attention-deficit/hyperactivity disorder. This medication is the first norepinephrine, dopamine, and serotonin reuptake inhibitor approved for this specific medical condition.

The authorization covers both adult and pediatric patients aged 6 years and older who weigh at least 20 kilograms. Clinical trials supporting this decision involved four phase 3 studies, which demonstrated that the drug is well tolerated and offers significant improvement in ADHD symptoms. Participants in these trials showed measurable progress as early as one week into treatment.

Data from the phase 3 trials indicated that adults experienced symptoms reduction, including an 18-point improvement on standardized rating scales by the sixth week compared to a placebo. Pediatric and adolescent participants also saw significant rating scale improvements when treated with high doses of the medication during controlled studies.

Commonly reported side effects for children included rash and decreased appetite. Adolescents reported those same symptoms alongside nausea, headache, and abdominal pain. Adults recorded insomnia, dry mouth, and diarrhea in addition to decreased appetite and headache.

The medication is expected to reach the market later this year, pending Drug Enforcement Administration scheduling. This approval adds a distinct mechanism of action to the current list of available medical options for patients managing this complex condition.