The U.S. Food and Drug Administration (FDA) has approved UZEDY® (risperidone) as a once-monthly, extended-release injectable suspension for adults with bipolar I disorder (BD-I). It can be used alone or alongside lithium or valproate for maintenance treatment. The decision draws on existing clinical data for UZEDY and leverages Model-Informed Drug Development (MIDD) methodologies, which build on prior findings about the safety and efficacy of risperidone formulations already cleared for BD-I.
UZEDY is the first subcutaneous, long-acting risperidone formulation to use SteadyTeq™, a proprietary copolymer technology from Medincell that controls the steady release of the drug. Therapeutic blood levels are typically reached within 6 to 24 hours after a single dose. For BD-I, the FDA approval covers three once-monthly dosing options—50 mg, 75 mg, and 100 mg.
“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “This expanded indication for UZEDY builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”
About 1% of U.S. adults, more than 3.4 million people are expected to develop BD-I in their lifetime. The disorder is linked to poor long-term outcomes and a significantly higher mortality rate than the general population, largely due to suicide and cardiovascular disease.
“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 Craig Chepke, MD, DFAPA, Medical Director at Excel Psychiatric Associates and Scientific Director for HMP Global’s Psych Congress programs. “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.”
UZEDY was first approved in the U.S. in 2023 for the treatment of schizophrenia in adults.
“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” said Christophe Douat, CEO of Medincell. “We’re proud that UZEDY is now available to support patients living with bipolar I disorder. This milestone highlights the exceptional regulatory and commercial execution of our partner, Teva.”
The FDA’s approval for the BD-I indication draws on prior agency findings supporting the safety and efficacy of risperidone formulations used in BD-I, as well as on long-term data for UZEDY itself. The treatment’s safety, efficacy, and tolerability were assessed in two Phase 3 studies, TV46000-CNS-30072 (the RISE Study) and TV46000-CNS-30078 (the SHINE Study), both evaluating UZEDY for schizophrenia.
