FDA approves schizophrenia, bipolar treatment

The FDA has approved Rykindo for extended-release injectable suspension for the treatment of schizophrenia, as well as monotherapy or adjunctive therapy for the maintenance treatment of bipolar 1 disorder in adults.

Rykindo (risperidone) manufacturer Luye Pharma, which announced the approval on Jan. 15, noted that the drug is administered through an intramuscular injection once every 2 weeks. It delivers the active ingredient, risperidone, through long-acting and extended-release microsphere technology.

“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,” Luye Pharma President Yang Rongbing said in a press release. “Rykindo is our first new drug developed in-house and approved for marketing in the U.S., demonstrating our longstanding commitment to serving patients around the world with innovative therapies.”

Risperidone was approved in China in 2021. The treatment development is progressing in Europe, with plans to launch in more countries later, according to the statement.