Luye submits NDA for schizophrenia, bipolar disorder therapy
Luye submitted an NDA to FDA for Rykindo risperidone extended-release microspheres (LY03004) to treat schizophrenia and bipolar disorder. Luye Pharma Group Ltd. (HKSE:2186) hopes to launch the injectable formulation of the generic risperidone in the U.S. and China by next year.
Johnson & Johnson (NYSE:JNJ) already markets a long-acting injectable formulation of risperidone as Risperdal Consta to treat bipolar disorder and as a maintenance treatment for bipolar I disorder. According to its U.S. label, oral antipsychotic supplementation should be given during the first three weeks of treatment with Risperdal Consta to maintain therapeutic levels until the main release of risperidone from the injection site has begun...