The Food and Drug Administration (FDA) has approved Erzofri® (paliperidone palmitate) extended-release injection as a monotherapy and as an adjunct therapy for mood stabilizers or antidepressants for the treatment of adult schizophrenia and schizoaffective disorder.
Erzofri is an atypical antipsychotic drug, administered by monthly intramuscular injection. Developed in China, the product obtained approval as a new drug in the United States through the FDA’s 505(b)(2) pathway. The efficacy of Erzofri is based on well-controlled studies comparing it to another monthly paliperidone palmitate extended-release injection suspension. The most common adverse reactions during treatment include somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.
Erzofri is available in 5 dosage strengths: 39mg/0.25mL, 78mg/0.5mL, 117mg/0.75mL, 156mg/mL, 234mg/1.5mL, 351mg/2.25mL. This product must be managed by healthcare providers. Patients who have not taken oral paliperidone or risperidone (oral or injection) should establish tolerance to oral paliperidone or risperidone before starting Erzofri.
Similar to other drugs in its class, Erzofri’s prescribing information includes a black box warning indicating an increased risk of death in elderly patients with dementia-related psychosis. Erzofri is not approved for use in these patients.
Reference: Luye Pharma announces US FDA approval of Erzofri® (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder. News release. Luye Pharma. July 28, 2024.
Note: The above information is compiled and edited by Luye Pharma (please correct any errors if found). It is provided for the latest information on globally marketed drugs to help Chinese patients understand international new drug developments. It is for internal discussions among healthcare professionals only and should not be used as a basis for medication. For specific medication guidelines, consult the attending physician.
