Luye Pharma Gains FDA Approval for ERZOFRI® to Treat Schizophrenia and Schizoaffective Disorder

PRINCETON, N.J., July 28, 2024 – Luye Pharma Group (Luye Pharma), a global pharmaceutical company renowned for its innovation in medication R&D, manufacturing, and sales, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for ERZOFRI® (paliperidone palmitate) extended-release injectable suspension. This new medication is designed for the treatment of schizophrenia and schizoaffective disorder in adults. Schizophrenia and schizoaffective disorder are both serious, chronic psychiatric conditions marked by recurring relapses, and antipsychotic medications are essential for managing these disorders. However, patient adherence to medication regimens is typically inconsistent. Long-acting injectable (LAI) antipsychotics, such as ERZOFRI, improve adherence by reducing the frequency of doses and minimizing the risk of patients skipping doses without their healthcare provider's knowledge.

ERZOFRI, which is administered monthly, is the first patented paliperidone palmitate long-acting injection developed in China to receive approval in the U.S. The product was granted a U.S. patent in 2023, which will remain valid until 2039. Approved under the 505(b)(2) pathway, ERZOFRI is expected to offer a new treatment option for patients following its launch. Publicly available data reveals that sales of paliperidone palmitate LAIs in the U.S. reached $2.897 billion in 2023.

ERZOFRI (paliperidone palmitate) extended-release injectable suspension is indicated for the treatment of schizophrenia and schizoaffective disorder in adults, both as monotherapy and as an adjunct to mood stabilizers or antidepressants. However, elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of mortality. ERZOFRI is contraindicated for patients with known hypersensitivity to paliperidone, risperidone, or any of the excipients in its formulation. Reactions such as anaphylaxis and angioedema have been reported.

Several warnings and precautions must be considered with ERZOFRI. There is an increased risk of cerebrovascular adverse reactions, including fatalities, in elderly patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS) is a potentially fatal condition associated with antipsychotic drugs and requires immediate discontinuation and close monitoring. Paliperidone can cause a modest increase in the corrected QT (QTc) interval, necessitating caution in patients with a history of cardiac arrhythmias or conditions predisposing to QT prolongation. The drug can also lead to Tardive Dyskinesia (TD), a syndrome of potentially irreversible, involuntary movements, particularly in elderly patients.

Metabolic changes such as hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain have been observed with atypical antipsychotics, including ERZOFRI. Hyperglycemia can be severe and may require discontinuation of the suspect drug. Dyslipidemia and weight gain warrant monitoring. Orthostatic hypotension and syncope have been reported, necessitating caution in patients with cardiovascular or cerebrovascular diseases. Falls, leukopenia, and neutropenia are also potential risks, and patients should have their complete blood count monitored if they have a history of low white blood cell count.

Other significant warnings include hyperprolactinemia, cognitive and motor impairment, seizures, dysphagia, priapism, and disruption of body temperature regulation. The most common adverse reactions include injection site reactions, somnolence, dizziness, akathisia, and extrapyramidal disorder. Drug interactions and use in specific populations, including pregnant and lactating women, require careful consideration.

The FDA's approval of ERZOFRI is based on an open-label, randomized study involving 281 patients with schizophrenia or schizoaffective disorder. The study demonstrated that ERZOFRI is bioequivalent to the listed drug INVEGA SUSTENNA® with a comparable safety profile.

Luye Pharma Group continues to expand its R&D and manufacturing capabilities globally, with a strong pipeline of drug candidates and a presence in over 80 countries. The company specializes in novel drug delivery technologies and aims to maintain high standards in the development of innovative medications across various therapeutic areas.

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