FDA Approves Erzofri (paliperidone palmitate) for the Treatment of Schizophrenia and Schizoaffective Disorder

FDA approves Erzofri (paliperidone palmitate) for treating schizophrenia and schizoaffective disorder in adults, as monotherapy or adjunct to mood stabilizers/antidepressants. Erzofri, a long-acting injectable developed in China, is the first of its kind to be approved in the U.S., offering improved patient adherence and reduced dosing frequency. It is contraindicated in patients with dementia-related psychosis and known hypersensitivity to paliperidone or risperidone. Safety concerns include increased mortality in elderly patients with dementia-related psychosis, cerebrovascular adverse reactions, neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia, metabolic changes, orthostatic hypotension, falls, leukopenia, neutropenia, agranulocytosis, hyperprolactinemia, cognitive and motor impairment, seizures, dysphagia, priapism, and disruption of body temperature regulation. Common adverse reactions include injection site reactions, somnolence, dizziness, akathisia, and extrapyramidal disorder.