FDA Approves First NDSRI for ADHD in Adults and Children

The FDA has approved centanafadine (Simtriyo), the first and only norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for the treatment of ADHD in adults and children ages 6 and older weighing at least 20 kg. The approval was based on four Phase 3 clinical trials showing statistically significant and clinically meaningful improvements in ADHD symptoms. Centanafadine is expected to become available later this year following U.S. Drug Enforcement Administration (DEA) scheduling.