Luye Pharma Group announced today that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension has officially launched in the United States market. The medication is indicated for the treatment of adults with schizophrenia and as both monotherapy and adjunct therapy for adults with schizoaffective disorder.
ERZOFRI represents a significant advancement in long-acting injectable (LAI) antipsychotic therapy, primarily through its simplified treatment initiation protocol. Unlike currently available monthly paliperidone palmitate injections that require two separate initiation doses on Day 1 and Day 8, ERZOFRI enables single-dose initiation with its unique 351 mg formulation.
Addressing Treatment Adherence Challenges
Both schizophrenia and schizoaffective disorder are characterized as severe, chronic psychiatric conditions with recurrent relapse patterns. Medication non-adherence remains one of the most significant challenges in managing these disorders.
"Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder," stated Rongbing Yang, President of Luye Pharma Group. "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."
Research indicates that failure of follow-up care after hospital discharge significantly increases patients' non-adherence to prescribed medications, leading to higher rates of relapse and rehospitalization. Long-acting injectable antipsychotics, with their reduced dosing frequency compared to daily oral medications, have demonstrated effectiveness in improving medication adherence.
Clinical Evidence and Availability
The FDA approval of ERZOFRI was based on an open-label, randomized, multiple-dose, parallel-group study that evaluated its pharmacokinetic profile and relative bioavailability compared to an established paliperidone palmitate LAI. The study demonstrated bioequivalence at steady state (treatment day 8) without requiring a second initiation injection, while maintaining a comparable safety profile.
Dr. Christoph U Correll, Professor of Psychiatry at Zucker School of Medicine at Hofstra/Northwell in New York, commented: "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."
In addition to the 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in multiple strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL, allowing for personalized maintenance dosing.
Safety Considerations
As with other antipsychotic medications, ERZOFRI carries important safety warnings. The most common side effects include injection site reactions, sleepiness or drowsiness, dizziness, restlessness, and abnormal muscle movements including tremor, shuffling, and uncontrolled involuntary movements.
Serious potential side effects include increased risk of death in elderly people with dementia-related psychosis (ERZOFRI is not approved for this population), cardiovascular problems, neuroleptic malignant syndrome, problems with heartbeat, tardive dyskinesia, and metabolic issues including hyperglycemia and weight gain.
Healthcare providers should carefully evaluate patients' medical history before prescribing ERZOFRI, particularly regarding cardiac conditions, diabetes risk factors, and history of seizures or movement disorders.
Strategic Importance for Luye Pharma
The U.S. launch represents a significant milestone for Luye Pharma Group, an international pharmaceutical company with research and development centers in China, the United States, and Europe. The company has positioned the central nervous system as a key therapeutic focus area.
"Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S.," Yang added. "We are committed to providing innovative therapies to combat mental disorders and expand treatment options."
Luye Pharma maintains a robust pipeline with over 20 drug candidates in China and more than 10 in other international markets. The company has established expertise in novel drug delivery technologies including microspheres, liposomes, and transdermal systems, with a global supply chain encompassing eight manufacturing sites worldwide.
Expanding Treatment Options
The introduction of ERZOFRI provides clinicians with an additional tool in the management of serious psychiatric disorders, potentially improving outcomes through enhanced medication adherence. The simplified initiation protocol addresses a key barrier in the early treatment phase, which is often critical for establishing therapeutic benefit and patient engagement.
For patients with schizophrenia and schizoaffective disorder, consistent medication adherence is essential for symptom control, relapse prevention, and quality of life improvement. ERZOFRI's once-monthly administration schedule and streamlined initiation may contribute to better treatment outcomes in these challenging conditions.
