The US Food and Drug Administration has broadened the indication for Uzedy (risperidone) to include its use as a long-acting injectable maintenance therapy—alone or alongside lithium or valproate—for adults with bipolar I disorder.

Uzedy was previously approved in 2023 for the treatment of schizophrenia in adults. The new indication is supported by existing clinical data and model-informed drug development methodologies that incorporate prior safety and efficacy findings from risperidone formulations approved for bipolar I disorder (BD-I).

Developed by Teva Pharmaceuticals in collaboration with Medincell, Uzedy is a subcutaneous, long-acting formulation of risperidone utilizing SteadyTeq copolymer technology to provide sustained drug release. Therapeutic plasma concentrations are achieved within 6 to 24 hours after a single dose. The BD-I indication includes three once-monthly dosing options: 50 mg, 75 mg, and 100 mg.

The US Food and Drug Administration’s decision is based on previously established data on risperidone in BD-I and clinical findings from the pivotal Uzedy schizophrenia trials—RISE (TV46000-CNS-30072) and SHINE (TV46000-CNS-30078)—which evaluated its efficacy, safety, and tolerability.

The most common adverse effects reported with risperidone include weight gain, somnolence, tremor, and injection site reactions. Uzedy carries a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis and is not approved for use in this population.

Source: Teva Pharmaceutical