The US Food and Drug Administration has approved SIMTRIYO, a new once-daily medication targeting neurotransmitter reuptake, offering an alternative for ADHD management across age groups and demonstrating rapid efficacy.
The US Food and Drug Administration has approved centanafadine, sold as SIMTRIYO, for attention-deficit/hyperactivity disorder in adults and in children aged six and older who weigh at least 20kg, widening the range of drugs available for a condition that can affect concentration, behaviour and daily functioning across the lifespan.
According to Otsuka Pharmaceutical, the medicine is a once-daily extended-release capsule and the first approved treatment in a new class known as norepinephrine, dopamine and serotonin reuptake inhibitors, or NDSRIs. By affecting the availability of those three neurotransmitters, it takes a different approach from many existing ADHD medicines, which may be useful for patients who have not responded well to standard options.
The FDA’s decision was based on four phase 3 trials in children, adolescents and adults. Otsuka said the studies showed statistically significant improvement in ADHD symptoms versus placebo, with benefits seen as early as the first week in paediatric and adult patients. Reporting by Healthline and Psychiatric Times also said follow-up analyses found gains in executive function, including time management, planning, task initiation, task completion and working memory.
Safety remains a key part of the picture. Otsuka said the most common side effects in children and adolescents were reduced appetite, nausea, rash, headache and abdominal pain, while adults most often reported headache, reduced appetite, insomnia, nausea, dry mouth and diarrhoea. Contemporary Pediatrics reported that the drug is expected to become available later this year after US Drug Enforcement Administration scheduling, and that it carries boxed warnings covering suicidal thoughts and behaviour in children, as well as abuse, misuse and addiction risks.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
