USFDA Approves Injectable Drug Treatment For Schizophrenia In Adults

The US Food and Drug Administration (FDA) has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Teva Pharmaceuticals' Uzedy is the first FDA-approved subcutaneous, long-acting risperidone formulation that uses novel SteadyTeq technology for the treatment of schizophrenia in this patient population. SteadyTeq is a MedinCell-developed copolymer technology that regulates risperidone release over time, requiring no oral supplementation or loading dose and reaching therapeutic blood concentrations within 6 to 24 hours of each dose.

The FDA approved the drug based on positive results from the SHINE Study—A Study to Test TV-46000 for Schizophrenia Maintenance Treatment (TV46000-CNS-30078) and the RISE Study—The Risperidone Subcutaneous Extended-Release Study (TV46000-CNS-30072). "UZEDY embodies Teva's commitment to bringing innovative advances to patients and to providing people living with schizophrenia with an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse," said Teva president and CEO Richard Francis in a press release. "The approval of UZEDY represents the culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market."