FDA approves Rykindo for the treatment of schizophrenia and bipolar 1 disorder
Luye Pharma Group announced that the 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. 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.
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.
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