The US Food & Drug Administration (FDA) gave its approval last week to oral centanafadine (Simtriyo), a first-in-class triple reuptake inhibitor for attention deficit-hyperactivity disorder (ADHD), reports MedPage Today.
Manufacturer Otsuka said the once-daily extended-release capsule – a norepinephrine, dopamine, and serotonin reuptake inhibitor that functions as a central nervous system stimulant – is indicated for patients aged six years and older who weigh at least 20kg.
Approval was supported by results from four randomised, double-blind, placebo-controlled phase 3 trials: two studies in adults and two in paediatric and adolescent populations.
Across the studies, centanafadine showed statistically significant and clinically meaningful improvements in ADHD symptoms as measured by the ADHD Rating Scale-5 in children and adolescents and the Adult ADHD Investigator Symptom Rating Scale in adults.
Symptom improvements were observed as early as week one.
The most common adverse reactions were rash and decreased appetite in children aged six to 12; decreased appetite, nausea, rash, headache, and abdominal pain in teens aged 13 to 17; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhoea in adults.
The drug’s label carries boxed warnings for a risk of suicidal ideation and behaviours in paediatric patients, as well as for the potential for abuse, misuse, and addiction.
Additional warnings include risks for patients with serious cardiac disease, increased blood pressure and heart rate, adverse psychiatric reactions, hypersensitivity reactions, long-term growth suppression in children, peripheral vasculopathy, serotonin syndrome, and tics.
Centanafadine is not recommended for children under six, and is contraindicated in patients with known hypersensitivity to centanafadine, those taking or within 14 days of discontinuing a monoamine oxidase inhibitor, and patients with a history of pheochromocytoma.
Otsuka said the drug will be available later this year after drug scheduling. Centanafadine also recently showed success in a phase IIIb study of adults with ADHD and comorbid anxiety.
MedPage Today article – First-in-Class Drug for ADHD Wins FDA Approval (Open access)
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