The FDA has approved UZEDY, a once-monthly, extended-release risperidone injectable developed by Teva Pharmaceuticals and Medincell, for the maintenance treatment of adults with bipolar I disorder. The drug can be administered as monotherapy or in combination with lithium or valproate, providing a new long-acting option for patients requiring sustained management of manic and depressive episodes.
UZEDY employs Medincell’s SteadyTeq copolymer technology, enabling a consistent subcutaneous release of risperidone with therapeutic blood concentrations achieved within six to twenty-four hours of injection. The FDA’s decision was based on existing clinical data, model-informed development methodologies, and prior evidence from risperidone’s established use in bipolar disorder and schizophrenia. The formulation was previously approved in 2023 for adult schizophrenia treatment.
An estimated 3.4 million adults in the United States live with bipolar I disorder, a condition associated with high relapse rates and increased mortality, often driven by challenges in adhering to daily oral medication regimens. Long-acting injectables like UZEDY aim to improve compliance and reduce relapse frequency by maintaining steady therapeutic drug exposure between doses.
Chris Fox, Teva’s executive vice president for U.S. commercial operations, described the approval as an important step toward addressing unmet needs in serious mental illness, while Medincell CEO Christophe Douat highlighted the role of long-acting injectables in advancing central nervous system therapeutics. UZEDY will be available in 50 mg, 75 mg, and 100 mg monthly dosing options.
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