Princeton, N.J. — The U.S. Food and Drug Administration has approved Otsuka’s Simtriyo for the treatment of attention-deficit hyperactivity disorder in adults and children ages 6 and older who weigh at least 20 kilograms.
Simtriyo, also known as centanafadine, is a once-daily extended-release capsule and the first approved norepinephrine, dopamine and serotonin reuptake inhibitor for ADHD. Otsuka expects to make the treatment commercially available later this year after it is scheduled by the U.S. Drug Enforcement Administration.
The central nervous system stimulant works by inhibiting the reuptake of norepinephrine, dopamine and serotonin, increasing the availability of neurotransmitters involved in attention and behavioral regulation.
The approval was supported by four randomized, double-blind, placebo-controlled Phase 3 trials involving children, adolescents and adults with ADHD.
In the studies, Simtriyo produced statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo. Improvements were observed as early as the first week of treatment in both pediatric and adult patients.
“The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Otsuka. “ADHD is a complex and highly individualized disorder that can affect people throughout childhood, adolescence, and adulthood. Today’s approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families managing ADHD. We are deeply grateful to the patients, caregivers, investigators, and clinical teams whose participation made this achievement possible.”
In the two pivotal adult studies, both centanafadine dose groups significantly improved scores on the Adult ADHD Investigator Symptom Rating Scale compared with placebo. The benefits emerged by the first week and were maintained throughout the six-week treatment period.
In pediatric and adolescent studies, the higher centanafadine dose significantly improved scores on the ADHD Rating Scale-5 compared with placebo, with benefits also appearing during the first week.
The most common adverse reactions in children ages 6 to 12 were rash and decreased appetite. Among adolescents, common reactions included decreased appetite, nausea, rash, headache and abdominal pain.
In adults, the most common adverse reactions included headache, decreased appetite, insomnia, nausea, dry mouth and diarrhea.
“ADHD can significantly affect many aspects of daily life across school, work, and relationships,” said Lenard A. Adler, M.D., Director of the Adult ADHD Program at NYU Langone Health. “Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning. The approval of SIMTRIYO introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients. Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient.”
Otsuka also recently completed a Phase 3b trial evaluating centanafadine in adults with ADHD and anxiety. The study showed statistically significant improvements in ADHD symptoms compared with placebo, and full findings are expected to be presented at an upcoming scientific meeting.
ADHD is a chronic neurodevelopmental disorder associated with difficulties involving attention, hyperactivity and impulsivity. It affects an estimated 7 million children and 15.5 million adults in the United States.
