The risperidone formulation is the first FDA-approved treatment for this patient population to use technology enabling controlled release over time.
Uzedy (risperidone) extended-release injectable suspension has been approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia in adults.
Uzedy, a product of Teva Pharmaceuticals, is now the first subcutaneous, long-acting formulation of risperidone that uses novel SteadyTeq to be approved by the FDA for the treatment of schizophrenia in this patient population. SteadyTeq is a copolymer technology proprietary to MedinCell that controls the release of risperidone over time, requiring no oral supplementation or loading dose and reaching therapeutic blood concentrations within 6 to 24 hours of each dose.1
The FDA based its decision to approve the drug based on positive results from the SHINE Study—A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia (TV46000-CNS-30078) and the RISE Study—The Risperidone Subcutaneous Extended-Release Study (TV46000-CNS-30072).1
“UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, Teva president and CEO, in a press release. “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market.”
1. Teva and MedinCell announce FDA approval of UZEDY (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults. BusinessWire. News release. April 28, 2023. Accessed May 1, 2023. https://www.businesswire.com/news/home/20230428005389/en/Teva-and-MedinCell-Announce-FDA-Approval-of-UZEDY%E2%84%A2-risperidone-Extended-Release-Injectable-Suspension-a-Long-Acting-Subcutaneous-Atypical-Antipsychotic-Injection-for-the-Treatment-of-Schizophrenia-in-Adults