FDA Accepts sNDA for Uzedy Extended-Release Injectable Suspension for Bipolar I Disorder

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The US Food and Drug Administration (FDA) has accepted for filing Teva Pharmaceuticals’ supplemental New Drug Application (sNDA) for risperidone (Uzedy) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults. The sNDA is based on leveraging the existing clinical data for Uzedy along with previous findings of safety and efficacy of past risperidone formulations approved for treating bipolar I disorder.¹

“Since the FDA approval of Uzedy almost 2 years ago, it has proven to be an important treatment option for people living with schizophrenia,” 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. Debilitating manic and depressive symptoms and signs can also occur.”

Uzedy was first approved in the US in 2023 for the treatment of adults with schizophrenia. Moving forward, Teva will lead the regulatory process and be responsible for potential commercialization of Uzedy for bipolar I disorder, while Medincell will be eligible for royalties on net sales.

“Long-acting injectables are key drivers of innovation in the CNS field today,” said Richard Malamut, MD, chief medical officer at Medincell. “In bipolar I disorder, as in schizophrenia, nonadherence remains a major barrier to effective care, one that Uzedy has the potential to help. We are proud to partner with Teva to deliver treatment options aimed at meeting unmet medical needs.”

The efficacy and long-term safety and tolerability of Uzedy for the treatment of schizophrenia have been evaluated in 2 phase 3 pivotal studies: the RISE Study (Risperidone Subcutaneous Extended-Release Study) and the SHINE Study (Safety in Humans of TV-46000 sc INjection Evaluation).²

The RISE study, was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients (aged 13 to 65 years) with schizophrenia. Approximately 544 patients were randomized to receive a subcutaneous injection of Uzedy once monthly, once every 2 months, or placebo in a 1:1:1 ratio. The primary endpoint was time to impending relapse.³

The SHINE study was designed to evaluate the long-term safety, tolerability and efficacy of Uzedy subcutaneously administered once monthly or once every 2 months for up to 56 weeks in 331 patients (aged 13 to 65 years) with schizophrenia. The primary endpoint was the frequency of all adverse events, including serious adverse events.⁴

The safety and efficacy of Uzedy for bipolar I disorder are not established and Uzedy is not approved for this indication.

References

1. Teva and Medincell announce FDA acceptance of supplemental new drug application for UZEDY(R) (risperidone) extended-release injectable suspension as a treatment for patients with bipolar I disorder. News release. February 25, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Medincell-Announce-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-UZEDYR-risperidone-Extended-Release-Injectable-Suspension-as-a-Treatment-for-Patients-with-Bipolar-I-Disorder/default.aspx

2. Correll CU. New data on the subcutaneous long-acting injectable antipsychotic formulation of risperidone. Psychiatric Times. July 31, 2024. https://www.psychiatrictimes.com/view/new-data-on-the-subcutaneous-long-acting-injectable-antipsychotic-formulation-of-risperidone

3. Kane JM, Harary E, Eshet R, et al. Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria. Lancet Psychiatry. 2023;10(12):934-943.

4. Kane JM, Eshet R, Harary E, et al. A long-term safety and tolerability study of TV-46000 for subcutaneous use in patients with schizophrenia: a phase 3, randomized, double-blinded clinical trial. CNS Drugs. 2024;38(8):625-636.