VLuye Pharma Launches Erzofri ER in US for Schizophrenia Treatment

Luye Pharma Group, an international pharmaceutical company, announced that Erzofri (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the US for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder.

Erzofri, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8.

Erzofri may cause serious side effects, including:

Increased risk of death in elderly people with dementia-related psychosis. Erzofri increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Erzofri is not for the treatment of people with dementia-related psychosis. The most common side effects of Erzofri include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients' non-adherence to prescribed medications, relapse and rehospitalization. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen.

Erzofri's approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of Erzofri to the listed drug at steady state (treatment day 8) without the need for a second initiation injection.

Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, Erzofri is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL.

""This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals."" said Christoph U Correll, MD, Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, USA.

Rongbing Yang, president of Luye Pharma Group, added: ""Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. Erzofri, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage. Its commercial launch in the US marks a major milestone in our commitment to addressing the unmet medical needs of patients in the US. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options.""

Erzofri (paliperidone palmitate) extended-release injectable suspension.

Erzofri is a prescription medicine given by injection by a healthcare provider and used to treat:

schizophrenia in adults
schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants
It is not known if Erzofri is safe and effective in children.

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centres in China, the US and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets.

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