FDA approves long acting extended-release injection for treating Schizophrenia

The US Food and Drug Administration has approved a new long acting monthly paliperidone palmitate (Erzofri) extended-release injectable suspension for treating schizophrenia in adults.

Paliperidone palmitate is an atypical antipsychotic indicated for schizoaffective disorder in adults, as monotherapy or adjunct to mood stabilizers or antidepressants.

Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring relapses. Antipsychotic medications play an important role in treating and controlling symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dosing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers.

ERZOFRI, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S. The product was granted a U.S. patent (Patent No.11,666,573) in 2023, which will expire in 2039. ERZOFRI is approved as a new drug under the 505(b) (2) pathway in the U.S.

According to publicly available information, the sales of paliperidone palmitate LAIs were $2.897 billion across the U.S. in 20233. ERZOFRI will provide patients with a new treatment option after its launch.

ABOUT ERZOFRI®

What is ERZOFRI (paliperidone palmitate) extended-release injectable suspension?

ERZOFRI is an atypical antipsychotic indicated for:

• The treatment of schizophrenia in adults.

• The treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

About the Clinical Trial

The U.S. FDA approval of ERZOFRI is based on the results of an open-label, randomized, multiple-dose, parallel-group study that enrolled 281 patients (ages 18-65) with schizophrenia or schizoaffective disorder (NCT04922593), designed to evaluate the PK profile of ERZOFRI and its relative bioavailability compared with the listed drug INVEGA SUSTENNA®. ERZOFRI was demonstrated to be bioequivalent to the listed drug at steady state after multiple injections. Compared with the listed drug, the initial dosing was optimized for ERZOFRI by omitting the injection on Day 8 after the first injection, resulting in a comparable total drug exposure.

The safety profile of ERZOFRI was consistent with the known safety profile of the listed drug.