FDA Approves Luye Pharma's Rykindo® for the Treatment of Schizophrenia and Bipolar 1 Disorder

• Rykindo^® is a bi-weekly long-acting risperidone injection and is the first innovative therapy from Luye Pharma's Central Nervous System (CNS) product portfolio to be marketed in the United States.

PRINCETON, N.J., Jan. 15, 2023 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved Rykindo^® (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

Rykindo^® was developed by Luye Pharma on its microsphere technology platform. The drug is administered via intramuscular injection once every two weeks and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology.

Schizophrenia and bipolar disorder are both severe mental disorders. There were 40 million sufferers of bipolar disorder worldwide in 2019, and currently around 24 million schizophrenia patients^[1]. In the U.S., the estimated prevalence of schizophrenia and related psychotic disorders ranges between 0.25% and 0.64%^[2], while an estimated 4.4% of U.S. adults experience bipolar disorder at some point in their lives^[3].

"Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and the society. Rykindo^® is our first new drug developed in-house and approved for marketing in the U.S., demonstrating our long-standing commitment to serving patients around the world with innovative therapies," said Yang Rongbing, President of Luye Pharma Group. "At Luye Pharma, we continue to enrich our product portfolio in the CNS field by focusing on the unmet needs of patients, and we look forward to making further contributions to the mental health community by providing better care and better services to those in need."

Rykindo^® was approved for marketing in China in 2021 for the treatment of schizophrenia. The development of Rykindo^® in Europe is progressing, with plans to launch the drug in more countries and regions around the world.

The central nervous system is a key therapeutic area of focus for Luye Pharma. The company has built a robust product portfolio in the field, including a number of commercialized products and drug candidates, covering multiple diseases such as depression, Parkinson's disease, schizophrenia, bipolar disorder and Alzheimer's disease.

About Rykindo^®

Developed by Luye Pharma, Rykindo^® is administered via intramuscular injection once every two weeks and delivers its active ingredient, risperidone, via long-acting and extended-release microsphere technology.

Rykindo^® is an atypical antipsychotic indicated:

• for the treatment of schizophrenia in adults.
• as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

Important Safety Information

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

See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Rykindo^® is not approved for use in patients with dementia-related psychosis.

Contraindications

Rykindo^® should not be administered to patients with known hypersensitivity to risperidone, paliperidone, or to any components in Rykindo^®.

Warnings and Precautions

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemia attack).
• Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring.
• Tardive Dyskinesia: Discontinue treatment if clinically appropriate.
• Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
• Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. Long-standing hyperprolactinemia, when associated with hypogonadism, can lead to decreased bone density in males and females.
• Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular disease or cerebrovascular disease, and risk of dehydration or syncope.
• Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood cell counts (CBC) in patients with a history of clinically significant low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Rykindo^® if clinically significant decline in WBC occurs in the absence of other causative factors.
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery.
• Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
• Priapism: Priapism has been reported during postmarketing use of other risperidone products. Severe priapism may require surgical intervention.

Adverse Reactions

The most common adverse reactions in patients with schizophrenia (? 5%) were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremity, and dry mouth.

The most common adverse reactions in patients with bipolar disorder were (5% in monotherapy trial) weight increased and (? 10% in adjunctive therapy trial) tremor and parkinsonism.

Please see full Prescribing Information at https://www.luye.cn/lvye_en/rykindo.pdf 

About the Clinical Trials of Rykindo^®

Clinical trials of Rykindo^® include:

• An open-label, single-ascending dose pharmacokinetic and safety study of LY03004 following escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder (NCT02055287)
• A randomized, open-label, parallel-group study to assess the relative bioavailability of LY03004 and Risperdal^® Consta^® at 25 mg following multiple intramuscular injections in stable patients with schizophrenia or schizoaffective disorder (NCT02091388)
• A randomized open-label pharmacokinetic study of LY03004 compared to Risperdal^® Consta^® following a single intramuscular injection at 25mg or 50mg in stable patients with schizophrenia and/or schizoaffective disorder (NCT02186769)

About Schizophrenia

Schizophrenia is a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Although the course of schizophrenia varies among individuals, schizophrenia is typically persistent and can be both severe and disabling^[2]. Schizophrenia affects approximately 24 million people or 1 in 300 people worldwide^[1]. Estimates of the prevalence of schizophrenia and related psychotic disorders in the U.S. range between 0.25% and 0.64%^[2].

About Bipolar Disorder

Bipolar disorder is a mental illness that causes unusual shifts in mood, energy, activity levels, concentration, and the ability to carry out day-to-day tasks^[4]. 40 million people experienced bipolar disorder worldwide in 2019^[1]. An estimated 4.4% of U.S. adults experience bipolar disorder at some time in their lives^[3].

Bipolar disorder is a category that includes three different diagnoses: bipolar I, bipolar II, and cyclothymic disorder. Bipolar I disorder is diagnosed when a person experiences a manic episode. During a manic episode, people with bipolar I disorder experience an extreme increase in energy and may feel on top of the world or uncomfortably irritable in mood. Some people with bipolar I disorder also experience depressive or hypomanic episodes, and most people with bipolar I disorder also have periods of neutral mood.^[5]

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 30 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 with over 30 production lines in total, establishing GMP quality management and international standard control systems. 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.  Mental disorders. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed in January 2023

2.  Schizophrenia. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/schizophrenia. Accessed in January 2023

3.  Bipolar Disorder. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/bipolar-disorder. Accessed in January 2023

4.  Bipolar Disorder. National Institute of Mental Health. https://www.nimh.nih.gov/health/topics/bipolar-disorder. Accessed in January 2023

5.  What Are Bipolar Disorders? American Psychiatric Association. https://www.psychiatry.org/patients-families/bipolar-disorders/what-are-bipolar-disorders. Accessed in January 2023

SOURCE Luye Pharma