Federal regulators have approved SIMTRIYO, a daily extended-relief tablet containing centanafadine, to treat attention deficit hyperactivity disorder in adults and children 6 years and older weighing at least 44 pounds, according to Otsuka Pharmaceutical. The medication is the first norepinephrine, dopamine, serotonin reuptake inhibitor authorized for the condition and is expected to be available by prescription later this year following federal Drug Enforcement Administration scheduling hearings.
FDA Approves Centanafadine Tablet for ADHD Treatment
Otsuka Pharmaceutical secured Food and Drug Administration approval for SIMTRIYO, marking the introduction of a novel norepinephrine, dopamine, serotonin reuptake inhibitor class for managing the complex condition, according to company officials. John Kraus, MD, executive vice president and chief medical officer for Otsuka, stated that the authorization represents an important milestone for patients and healthcare professionals. The daily extended-relief tablet is authorized for adults and children 6 years and older who meet a minimum weight requirement of 44 pounds.
Clinical Trial Results and Patient Demographics
The safety and effectiveness of SIMTRIYO are supported by results from four phase 3 clinical trials involving adults, adolescents, and children, according to Otsuka data. Trials showed that participants using the medication demonstrated statistically significant and clinically meaningful symptom improvements compared to placebo groups. Two studies evaluated adults aged 18 to 55 receiving 200 milligrams or 400 milligrams of centanafadine. Additional evaluations included 459 adolescents aged 13 to 17 and 480 children aged 6 to 12. A separate phase 3b study focused on adults with the condition and comorbid anxiety, reporting similar symptom reductions over placebo.
Did you know? According to Centers for Disease Control and Prevention estimates, 7 million children ages 3 to 17 and 15 million adults in the United States have an attention deficit hyperactivity disorder diagnosis, with more than half of adult cases diagnosed in adults.
Expert Perspectives on Medical Management and Risks
Daniel Ganjian, MD, a pediatrician at Providence Saint John’s Health Center in California, stated that the new drug adds valuable tools for patients who haven’t found success with existing options. Ganjian noted that targeting three neurotransmitters could drive effectiveness, though he highlighted a boxed label warning for suicidal ideation and behaviors in pediatric patients, alongside risks for abuse, misuse, and addiction. Max Wiznitzer, MD, a professor of pediatrics and neurology at Case Western Reserve University and co-chair of the Professional Advisory Board for the organization Children and Adults with ADHD, added that he views the treatment as a useful backup alternative while awaiting further comparative evidence against stimulant-based medications.
Frequently Asked Questions
What is SIMTRIYO?
SIMTRIYO is a daily extended-relief tablet containing centanafadine, approved by the FDA as the first norepinephrine, dopamine, serotonin reuptake inhibitor for attention deficit hyperactivity disorder.
Who can take this medication?
The drug is authorized for adults and pediatric patients aged 6 years and older who weigh at least 44 pounds, according to Otsuka Pharmaceutical.
What are the reported side effects?
Clinical trials identified common side effects including decreased appetite, nausea, rash, headache, and abdominal pain in younger patients, alongside insomnia, dry mouth, and diarrhea in adults.
When will the prescription become available?
Otsuka expects the medication to launch later this year, pending Drug Enforcement Administration scheduling hearings.
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