Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults.

The approval is based on existing clinical data for UZEDY, coupled with Model-Informed Drug Development (MIDD) methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for BD-I.

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to Medincell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1 For the BD-I indication, UZEDY is now approved with three once-monthly dosing options (50 mg, 75 mg and 100 mg).

“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “This expanded indication for UZEDY builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”

“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” said Craig Chepke, MD, DFAPA, Medical Director, Excel Psychiatric Associates and Scientific Director, HMP Global’s Psych Congress events and programs. “The FDA’s decision to expand the indication for UZEDY may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease.”

UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.

“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” said Christophe Douat, CEO of Medincell. “We’re proud that UZEDY is now available to support patients living with bipolar I disorder. This milestone highlights the exceptional regulatory and commercial execution of our partner, Teva.”