FDA Approves Erzofri for the Treatment of Schizophrenia and Schizoaffective Disorder
Luye Pharma Group announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S.
- Antipsychotic medications are used to treat and control symptoms of schizophrenia and
schizoaffective disorder, but patient adherence to antipsychotics is generally poor. The use of longacting injectable (LAI) antipsychotics is effective in improving patient adherence. - Erzofri is not approved for use in patients with dementia-related psychosis, and the safety and
effectiveness of Erzofri in pediatric patients have not been established.
Source: Luye Pharma Group