Teva and Medincell Advance UZEDY for Bipolar I Treatment
FDA accepts sNDA for UZEDY, a long-acting injectable aimed at improving bipolar I disorder management.
Teva Pharmaceuticals and Medincell announced that the FDA has accepted their supplemental New Drug Application (sNDA) for UZEDY, an extended-release injectable suspension now being evaluated for the maintenance treatment of bipolar I disorder (BP-I) in adults. Building on UZEDY’s proven efficacy in schizophrenia, the application leverages existing clinical data and prior safety findings from risperidone-based treatments. If approved, UZEDY could offer a long-acting solution for BP-I patients, addressing challenges such as treatment adherence and symptom management.
Experts from both companies emphasized the critical need for innovative approaches in central nervous system disorders. Dr. Eric Hughes of Teva highlighted UZEDY’s potential in stabilizing mood fluctuations associated with BP-I, while Dr. Richard Malamut of Medincell underscored the importance of long-acting injectables in overcoming nonadherence, a major treatment barrier. As the FDA review progresses, Teva remains focused on regulatory approval and potential commercialization, with Medincell set to receive royalties upon market entry.
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