The US Food and Drug Administration (FDA) has approved an expanded indication for Teva Pharmaceuticals’ Uzedy (risperidone) extended-release injectable suspension, authorizing its use for the maintenance treatment of bipolar I disorder (BD-I) in adults.
The medication can now be prescribed as monotherapy or as adjunctive therapy alongside lithium or valproate. Uzedy is a subcutaneous, long-acting formulation of risperidone, developed by Teva and Medincell utilizing the latter’s proprietary SteadyTeq copolymer technology. The therapy is the long-acting subcutaneous formulation of Johnson and Johnson’s (J&J) Risperdal, which is approved as a treatment for schizophrenia and bipolar disorder. The subcutaneous formulation enables a controlled and steady release of risperidone, with therapeutic blood concentrations achieved within six to 24 hours of a single dose.
Previous Approval
In 2023, the US FDA approved Uzedy for the treatment of schizophrenia in adults. This latest approval is based on a combination of existing clinical data and Model-Informed Drug Development (MIDD) methodologies, which drew upon established findings on risperidone’s safety and efficacy in bipolar disorder.
“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” said Dr. Craig Chepke, Medical Director of Excel Psychiatric Associates and Scientific Director of HMP Global’s Psych Congress. “The FDA’s decision to expand the indication for Uzedy may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease.”
The FDA’s review included prior data on risperidone formulations approved for BD-I as well as results from two Phase III studies, RISE (NCT03503318) and SHINE (NCT03893825), which evaluated Uzedy’s safety, tolerability, and efficacy in patients with schizophrenia. These trials demonstrated that the therapy effectively reduces relapse risk while maintaining stable therapeutic levels over extended periods.
Uzedy carries a boxed warning highlighting an increased risk of death in elderly patients with dementia-related psychosis; it is not approved for use in this population.
The new approval underscores a growing recognition of long-acting injectable (LAI) therapies as critical tools for improving adherence and outcomes in mental health care. Unlike traditional oral medications, LAIs minimize the risk of missed doses and reduce relapse frequency, providing more consistent symptom control for patients managing chronic psychiatric disorders.
