FDA Accepts Review of UZEDY for Bipolar I Disorder Treatment Extension
Key Insights
Teva and Medincell (search) announce FDA acceptance of supplemental New Drug Application for UZEDY as a maintenance treatment for bipolar I disorder (search) in adults, expanding from its current schizophrenia (search) indication.
The application leverages existing UZEDY clinical data and previous FDA findings on risperidone formulations for bipolar I disorder (search), potentially offering a new long-acting injectable treatment option.
If approved, UZEDY would address medication adherence challenges in bipolar I disorder (search), which affects over 3.4 million U.S. adults and causes significant mood and behavioral disruptions.
Teva Pharmaceuticals and Medincell (search) have reached a significant milestone in their efforts to expand treatment options for bipolar I disorder (search) (BP-I), as the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension.
The application seeks approval for UZEDY as a maintenance treatment for adults with BP-I, building upon its existing FDA approval for schizophrenia (search) treatment. UZEDY currently serves as a subcutaneous long-acting injectable (LAI) administered every one or two months for adult schizophrenia patients.
Clinical Foundation and Strategic Approach
The sNDA submission strategically leverages existing UZEDY clinical data combined with the FDA's previous safety and efficacy findings for risperidone formulations in BP-I treatment. This approach reflects a comprehensive understanding of the medication's therapeutic potential across related psychiatric conditions.
"Since UZEDY's approval nearly two years ago, it has proven to be an important treatment option for people living with schizophrenia (search)," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "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 (search) represents a significant mental health challenge, affecting approximately 1% of U.S. adults – translating to over 3.4 million individuals. The condition manifests through dramatic mood swings between manic and depressive episodes, substantially impacting patients' quality of life and daily functioning.
Dr. Richard Malamut, Chief Medical Officer at Medincell (search), emphasized the importance of long-acting treatments: "Long-acting injectables are key drivers of innovation in the CNS field today. In bipolar I disorder (search), as in schizophrenia (search), nonadherence remains a major barrier to effective care, one that UZEDY has the potential to help."
Commercial and Development Partnership
Under the collaboration agreement, Teva will spearhead the regulatory process and potential commercialization of UZEDY for BP-I. Medincell (search) stands to receive royalties on net sales, building upon their successful partnership that led to UZEDY's initial approval for schizophrenia (search) in 2023.
The medication utilizes Medincell (search)'s proprietary BEPO® technology, enabling sustained drug release over extended periods through a subcutaneous injection. This innovative delivery system could provide significant advantages for BP-I patients who struggle with medication adherence.
Safety and Development Status
While UZEDY has demonstrated efficacy and safety in schizophrenia (search) treatment through two Phase 3 studies – the RISE and SHINE trials – its safety and efficacy for BP-I remain under evaluation. The FDA's review of the sNDA will determine whether this long-acting formulation can offer a new treatment option for the BP-I patient population.