Uzedy Expanded to Include Bipolar I Maintenance

FDA has approved an expanded indication for Teva and Medincell’s Uzedy (risperidone) to permit its use as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of adults with Bipolar I disorder. The once-monthly extended-release injectable suspension for subcutaneous use was first approved in 2023 for treating schizophrenia in adults.

Approval was based on existing clinical data for Uzedy and model-informed drug development analyses that leveraged prior studies of risperidone formulations approved for Bipolar I disorder, the companies say. The agency also reviewed long-term safety and efficacy data from Uzedy’s schizophrenia development program, including the Phase 3 RISE and SHINE studies.

Uzedy uses Medincell’s SteadyTeq technology, a copolymer system that enables steady, controlled release of risperidone and achieves therapeutic levels within 6–24 hours of a single dose, they say.