Otsuka’s SIMTRIYO Receives FDA Approval for ADHD Treatment

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. have announced that the U.S. FDA has approved SIMTRIYO® (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older weighing at least 20 kg.

SIMTRIYO is the first approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) designed for ADHD management, offering a novel therapeutic approach by regulating neurotransmitter activity associated with attention and behavioral control. 

The central nervous system (CNS) stimulant is expected to become available later this year following scheduling by the U.S. Drug Enforcement Administration.

The FDA approval was supported by four Phase 3 clinical trials involving adult, adolescent, and pediatric patients. 

The studies demonstrated statistically significant improvements in ADHD symptoms compared with placebo, with benefits observed as early as the first week of treatment. 

Safety evaluations identified commonly reported adverse events, including decreased appetite, nausea, headache, insomnia, and gastrointestinal effects.

Otsuka stated that SIMTRIYO represents an important advancement in addressing the diverse treatment needs of individuals living with ADHD. 

Additional Phase 3b research evaluating centanafadine in adults with ADHD and anxiety has further expanded the clinical evidence supporting its potential.