FDA Accepts Teva and Medincell's sNDA for UZEDY in Bipolar I Disorder Treatment

Teva Pharmaceuticals and Medincell announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for UZEDY (risperidone) extended-release injectable suspension. The application seeks approval for UZEDY as a maintenance treatment for Bipolar I Disorder (BP-I) in adults.

Expanding UZEDY's Therapeutic Reach

UZEDY, currently approved in the U.S. for the treatment of schizophrenia in adults, is a subcutaneous long-acting injectable (LAI) administered every one or two months. The acceptance of the sNDA for BP-I represents a significant step in Teva's commitment to advancing neuroscience treatments.

Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, stated, "Today's filing demonstrates the potential of UZEDY's clinical profile as a long-acting treatment for bipolar-I, a complex mental health disorder that significantly affects a person's mood, behavior, and overall state of mind."

Addressing Unmet Needs in Bipolar I Disorder

Bipolar I Disorder affects an estimated 1% of U.S. adults in their lifetime, equivalent to over 3.4 million individuals. The condition is characterized by manic-depressive cycles that can severely impact quality of life and daily functioning.

Dr. Richard Malamut, Chief Medical Officer at Medincell, emphasized the importance of long-acting injectables in central nervous system treatments: "In bipolar I disorder, as in schizophrenia, nonadherence remains a major barrier to effective care, one that UZEDY has the potential to help."

Regulatory Process and Potential Commercialization

Teva will lead the regulatory process for UZEDY in BP-I and be responsible for potential commercialization. Medincell, which licenses the copolymer technology used in UZEDY to Teva under the name SteadyTeq, will be eligible for royalties on net sales.

The sNDA is based on existing clinical data for UZEDY, coupled with the FDA's previous findings of safety and efficacy for past risperidone formulations approved for BP-I treatment. While UZEDY has shown promise in schizophrenia treatment, its safety and efficacy for BP-I are not yet established, and it is not currently approved by any regulatory authority for this indication.