The Food adn drug Management (FDA) has expanded the approved use of Uzedy (risperidone) extended-release injectable suspension to include the treatment of manic or mixed episodes associated with Bipolar I Disorder in adults, Teva Pharmaceuticals announced September 4, 2025. Previously approved for schizophrenia,this broadened indication offers a new long-acting injectable option for managing acute mood episodes in individuals with Bipolar I Disorder.
This approval addresses a meaningful need for convenient and effective treatment modalities for Bipolar I Disorder, a chronic mental illness affecting approximately 2.8% of U.S. adults. The extended-release injectable formulation of risperidone aims to improve medication adherence, a critical factor in stabilizing mood and preventing relapse. Patients and healthcare providers now have an additional tool to manage the debilitating symptoms of mania and mixed episodes, potentially leading to improved quality of life and reduced hospitalizations.
Uzedy’s efficacy in treating Bipolar I Disorder was demonstrated in a clinical trial evaluating its impact on manic or mixed episode symptoms. The FDA’s decision is based on data showing significant improvements in patients receiving Uzedy compared to placebo.
Additionally, on September 4, 2025, the FDA approved Amneal Pharmaceuticals’ injectable extended-release suspension of risperidone for the treatment of schizophrenia, as reported by Pharmacy Times. This provides another long-acting injectable option for managing schizophrenia, offering potential benefits in terms of adherence and symptom control.
