These results were instrumental in securing the FDA approval of the drug for the treatment of schizophrenia in adults in April 2023.
Results from the Risperidone Subcutaneous Extended-Release (RISE) study have been released, indicating that the treatment under investigation significantly prolonged the time to impending relapse in patients with schizophrenia.
The RISE study—a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial—sought to evaluate the potential of Uzedy, a formulation of risperidone, as a long-acting injectable (LAI) antipsychotic treatment for adults with schizophrenia.1
The RISE study included 544 patients who were randomly assigned to receive a subcutaneous injection of Uzedy once every month (n=183) or once every 2 months (n=180), or a placebo (n=181). This patient pool was characterized by its diversity, with participants representing various racial backgrounds, including Black or African American (n=322), White (n=206), Hispanic or Latinx (n=117), Asian (n=7), and others.1
Key findings from the study revealed that Uzedy significantly prolonged the time to impending relapse in patients with schizophrenia. When administered once monthly, the treatment extended this time by a factor of 5.0 compared with placebo. For those receiving the injection once every 2 months, the extension was still notable at 2.7 times. This translated to a substantial reduction in the risk of relapse by 80% and 62.5%, respectively.1
“Relapse remains a significant and ongoing challenge for patients with schizophrenia as well as their caregivers and physicians, and these RISE study findings demonstrate Uzedy’s long-acting dosing has the potential to effectively prolong time to relapse,” said Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva Pharmaceuticals (developer of Uzedy), in a press release. “Importantly, a diverse patient population was enrolled in the study, reflecting Teva’s commitment to health equity in research and development as well as ensuring there are clinical insights into the role of Uzedy for every community impacted by schizophrenia.”
The RISE study also demonstrated that Uzedy achieved clinically relevant plasma concentrations within 24 hours of administration and maintained them consistently over flexible dosing intervals. The treatment’s safety profile was found to be consistent with other approved formulations of risperidone. These results were recently published in The Lancet Psychiatry.1
Results from the RISE study were instrumental in securing the approval of Uzedy by the US Food & Drug Administration (FDA) for the treatment of schizophrenia in adults in April 2023. Uzedy is 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.2
“Helping prevent relapses in my patients who live with schizophrenia is critical to protecting their health and goals,” said Christoph Correll, MD, practicing physician and professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, in a press release. “The RISE study demonstrates that a long-acting treatment option of a proven antipsychotic molecule may mitigate the risk of relapse, helping address the needs and preferences of patients with schizophrenia.”
Stay up-to-date on news related to research on promising new treatments for schizophrenia and a wide variety of other psychiatric disorders at psychiatrictimes.com.
Note: Assistance from ChatGPT was used in the preparation of this article.
1. Uzedy (risperidone) extended-release injectable suspension significantly prolongs time to schizophrenia relapse in RISE Study results published in The Lancet Psychiatry. Teva Pharmaceutical Industries Limited. News release. November 1, 2023. Accessed November 3, 2023. https://www.tevausa.com/news-and-media/press-releases/uzedy-risperidone-extended-release-injectable-suspension-significantly-prolongs-time-to-schizophrenia-/
2. O’Brien E. FDA approves long-acting treatment for schizophrenia in adults. Psychiatric Times. May 1, 2023. Accessed November 3, 2023. https://www.psychiatrictimes.com/view/fda-approves-long-acting-treatment-for-schizophrenia-in-adults