The U.S. Food and Drug Administration (FDA) has approved extended-release injectable suspension of risperidone (UZEDY, Teva) for the treatment of schizophrenia in adults.
This new approval is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. It utilizaes this copolymer technology to slowly release the active ingredient, risperidone, over a period of one to two months.
The approval was based on data data from two phase 3 trials: Risperidone Subcutaneous Extended-Release Study, or the RISE study, and the Study to Test TV-46000 for Maintenance Treatment of Schizophrenia, or the SHINE Study. Both studies showed the drug is well tolerated with a good safety profile and can reduce relapse in schizophrenia by up to 80 percent.
>> Teva and MedinCell Press Release