Rykindo (risperidone) Long-Acting Schizophrenia Med Gets FDA Nod

The US Food and Drug Administration (FDA) has approved Luye Pharma’s Rykindo (risperidone) for the treatment of schizophrenia and as a monotherapy or adjunctive therapy for the maintenance treatment of bipolar I disorder in adults.

Rykindo is formulated as an extended-release injectable suspension administered via intramuscular injection once every two weeks. The active ingredient, risperidone, is delivered via long-acting and extended-release microsphere technology developed by Luye Pharma on its microsphere technology platform.

Both schizophrenia and bipolar disorder are severe mental disorders. In 2019, there were 40 million bipolar disorder sufferers worldwide, and currently around 24 million schizophrenia patients. In the US, the estimated prevalence of schizophrenia and related psychotic disorders ranges between 0.25 percent and 0.64 percent, while an estimated 4.4 percent of US adults experience bipolar disorder at some point in their lives, according to statistics from the World Health Organization (WHO) and National Institutes of Health (NIH).

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Rykindo will be rivaling Johnson & Johnson’s long-acting risperidone product Risperdal Consta, which is administered either orally or via injection. The injectable versions can last between two to four weeks. Johnson & Johnson won FDA approval for Risperdal Consta about 20 years ago and has since come out with other drugs with different active ingredients that are administered as infrequently as twice a year.

Johnson & Johnson has dominated the space with its schizophrenia portfolio that also includes Invega Sustenna, Invega Trinza and Invega Hafyera — the latter was approved in 2021 as the first and only twice-yearly injectable to treat schizophrenia in adults.

Teva is also hopeful that its risperidone formulation will get the FDA green light soon. It was initially rejected by the agency, allowing Luye to get into the market before Teva.

Rykindo’s approval was based on a set of clinical trials, including two studies that compared its formulation to J&J’s Risperdal Consta.

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In a press release, Yang Rongbing, President of Luye Pharma Group, said, “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 US, demonstrating our long-standing commitment to serving patients around the world with innovative therapies.”

China-based Luye Pharma has a strong therapeutic focus on central nervous system disorders with a number of commercialized products and drug candidates for diseases including depression, Parkinson’s disease, schizophrenia, bipolar disorder and Alzheimer’s disease.

Rykindo received marketing approval in China in 2021 for the treatment of schizophrenia and development in Europe is progressing, according to Luye. The company says it plans to launch the drug in more countries and regions around the world.