Luye Pharma Announces U.S. Launch of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for the Treatment of ...

PRINCETON, N.J., April 6, 2025 - Luye Pharma Group today announced that ERZOFRI^® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. 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 relapses¹. 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 rehospitalization². 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 regimen³.

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 U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. 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
INDICATIONS

What is ERZOFRI^® (paliperidone palmitate)?

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.


IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate)
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.

Do not receive ERZOFRI if you are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI.

What are the possible serious side effects of ERZOFRI?

Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.

Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms:

• high fever
• stiff muscles
• confusion
• sweating
• changes in your breathing, pulse, heart rate, or blood pressure

​Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms:

• passing out or feeling like you will pass out
• dizziness
• feeling as if your heart is pounding or missing beats

Uncontrolled body movements (tardive dyskinesia). ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI.

Problems with your metabolism such as:

• High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI.
  Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI:​
  • feel very thirsty
  • feel very hungry
  • feel sick to your stomach
  • need to urinate more than usual
  • feel weak or tired
  • feel confused, or your breath smells fruity
• Increased fat levels (cholesterol and triglycerides in your blood). Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI.
• Weight gain. You and your healthcare provider should check your weight regularly during treatment with ERZOFRI.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls. ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Low white blood cell counts. Your healthcare provider may do blood tests during treatment with ERZOFRI.

Increased prolactin levels in your blood (hyperprolactinemia). ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.

Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities.

Seizures (convulsions).

Difficulty swallowing that can cause food or liquid to get into your lungs.

Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.

Problems with control of your body temperature so that you feel too warm.


Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you:

• have never taken paliperidone or risperidone before
• have had neuroleptic malignant syndrome (NMS)
• have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
• have or had low levels of potassium or magnesium in your blood
• have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia)
• have or had kidney or liver problems
• have or had high blood sugar, diabetes or have a family history of diabetes
• have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• have Parkinson's disease or a type of dementia called Lewy Body Dementia
• have or had problems with dizziness or fainting or are being treated for high blood pressure
• have or had a low white blood cell count
• have or had seizures or epilepsy
• are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby.
  • If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
  • Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur.
• are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk.
  • Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.


The most common side effects of ERZOFRI include:

• injection site reactions
• sleepiness or drowsiness
• dizziness
• feeling restless or like you need to move
• abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or call 1-800- FDA-1088.


About Luye Pharma Group

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 centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast-growing emerging markets.

References:

1. Anne Rivelli, Veronica Fitzpatrick, Michael Nelson, et al. Real-world predictors of relapse in patients with schizophrenia and schizoaffective disorder in a large health system. Schizophrenia (Heidelb) (2024). DOI: 10.1038/s41537-024-00448-2.
2. Lee SY, et al. Outpatient Follow-Up Visit after Hospital Discharge Lowers Risk of Rehospitalization in Patients with Schizophrenia: A Nationwide Population-Based Study. Psychiatry Investig. 2015;12(4):425-33. DOI: 10.4306/pi.2015.12.4.425.
3. Carmela Benson, et al. Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder. J Manag Care Spec Pharm. 2024 Jun 3:1-13. DOI: 10.18553/jmcp.2024.23252.

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