The US Food and Drug Administration has approved centanafadine (SIMTRIYO) for the treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older weighing at least 20 kg, according to a press release from Otsuka Pharmaceutical Co., Ltd., and Otsuka Pharmaceutical Development & Commercialization, Inc. According to the company, centanafadine is expected to become available later this year after US Drug Enforcement Administration scheduling.
The approval was based on four phase 3 randomized, double-blind, placebo-controlled trials evaluating centanafadine in adults, adolescents, and pediatric patients with attention-deficit/hyperactivity disorder (ADHD). In the two adult studies, both centanafadine dose groups achieved statistically significant improvements in Adult ADHD Investigator Symptom Rating Scale total scores compared with placebo over 6 weeks. In the pediatric and adolescent studies, the high-dose regimen produced statistically significant improvements in ADHD Rating Scale-5 total scores compared with placebo. Improvements in ADHD symptoms were observed as early as 1 across the adult and pediatric studies.
Centanafadine inhibits the reuptake of norepinephrine, dopamine, and serotonin, increasing the availability of these neurotransmitters in pathways involved in attention and behavioral regulation. ADHD is a chronic neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity that may persist into adulthood.
Across the phase 3 clinical program, centanafadine was generally well tolerated, according to the company. The most common adverse reactions were rash and decreased appetite in patients aged 6 to 12 years; decreased appetite, nausea, rash, headache, and abdominal pain in adolescents aged 13 to 17 years; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.
Otsuka also reported that a phase 3b study in adults with ADHD and comorbid anxiety demonstrated statistically significant improvements in ADHD symptoms compared with placebo. The company stated that complete results will be presented at a future scientific meeting.
“Having more therapeutic choices is important because ADHD is a highly individualized condition, and treatment decisions should reflect the unique needs of each patient," said Lenard A. Adler, MD, director of the Adult ADHD Program at NYU Langone Health.
According to data cited in the press release from the Centers for Disease Control and Prevention, ADHD affects approximately 7 million pediatric patients and 15.5 million adults in the US.
Source: Otsuka Pharmaceutical Co., Ltd.
