• 29 Jul 2024
• Admin
• News Article

Luye Pharma Announces U.S. FDA Approval of ERZOFRI®

Luye Pharma Announces U.S. FDA Approval of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for Treating Schizophrenia and Schizoaffective Disorder

Overview

Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today 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.

About the Disorders

• Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring relapses [1]. 
• 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[2].

About ERZOFRI

• 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 2023[3]. 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.

IMPORTANT SAFETY INFORMATION FOR ERZOFRI

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ERZOFRI is not approved for use in patients with dementia-related psychosis.
• CONTRAINDICATIONS: ERZOFRI is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the ERZOFRI formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone.

WARNINGS AND PRECAUTIONS

• Cerebrovascular Adverse Reactions: In clinical trials in elderly patients with dementia-related psychosis, increased risk of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, have been reported in patients taking atypical antipsychotic medications compared to placebo. ERZOFRI is not approved for the treatment of patients with dementia-related psychosis.
• Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Manage with immediate discontinuation and close monitoring.
• QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
• Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause TD is unknown.

Risk for Developing TD

• The risk of developing TD and the likelihood that it will become irreversible appear to increase with the duration of treatment and the cumulative dose. 
• The syndrome can develop after relatively brief treatment periods, even at low doses. It may also occur after discontinuation of treatment. 
• TD may remit, partially or completely, if antipsychotic treatment is discontinued. 
• Antipsychotic treatment itself may suppress (or partially suppress) the signs and symptoms of the syndrome and may thus mask the underlying process. 
• The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
• If signs and symptoms of TD appear in a patient treated with ERZOFRI, drug discontinuation should be considered. 
• However, some patients may require treatment with ERZOFRI despite the presence of the syndrome.

Metabolic Changes: 

Atypical antipsychotic drugs have been associated with metabolic changes, including hyperglycemia, dyslipidemia, and body weight gain.

Hyperglycemia and Diabetes Mellitus: 

• Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with all atypical antipsychotics. 
• Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening glucose control. 
• Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics, including ERZOFRI, should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. 
• Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. 
• Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. 
• In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.