FDA approves Uzedy extended release SC in schizophrenia.- Teva Pharma + MedinCell
Teva Pharmaceuticals and MedinCell announced that the FDA has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Uzedy 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.
This approval is based on data from two Phase III trials evaluating Uzedy in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).In clinical trials, Uzedy reduced the risk of relapse by up to 80%. Uzedy administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release in the first subcutaneous injection.
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