Teva And MedinCell’s UZEDY® (Risperidone) Wins FDA Nod For New Use In Treating Bipolar I Disorder In Adults

Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell have announced that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) as a once-monthly extended-release injectable suspension for the maintenance treatment of adults with bipolar I disorder (BD-I). The treatment can be used either as monotherapy or in combination with lithium or valproate.

The FDA’s approval is supported by existing clinical data for UZEDY and informed by Model-Informed Drug Development (MIDD) methodologies, which incorporate prior findings on the safety and efficacy of risperidone formulations already approved for bipolar I disorder. UZEDY is the first subcutaneous, long-acting risperidone formulation that uses Medincell’s proprietary SteadyTeq copolymer technology. 

This technology allows a controlled and steady release of the drug, helping patients maintain consistent therapeutic levels. Blood concentrations reach effective levels within 6 to 24 hours after a single dose.  For bipolar I disorder, UZEDY will be available in three once-monthly dosing options—50 mg, 75 mg, and 100 mg—offering flexibility based on patient needs.

Chris Fox, Executive Vice President of U.S. Commercial at Teva, stated that adults living with bipolar I disorder experience severe manic and depressive episodes, and the FDA’s approval of UZEDY introduces a new long-acting treatment option that may help address treatment gaps. He emphasized that this expanded indication builds on the drug’s previous success in treating schizophrenia and reflects Teva’s commitment to developing innovative therapies for complex mental health conditions that significantly affect patients and their caregivers.

Bipolar I disorder affects about 1% of adults in the United States, translating to more than 3.4 million individuals. The disorder is associated with significant long-term challenges and higher mortality rates, particularly due to suicide and cardiovascular complications.

Dr. Craig Chepke, Medical Director at Excel Psychiatric Associates and Scientific Director for HMP Global’s Psych Congress, highlighted that adherence to daily oral medication is a common challenge for people with bipolar I disorder. He noted that the availability of a long-acting injectable such as UZEDY offers clinicians a valuable new option that could improve treatment adherence and long-term outcomes.

UZEDY was first approved in the United States in 2023 for the treatment of schizophrenia in adults. Christophe Douat, CEO of Medincell, commented that long-acting injectables are becoming key innovations in central nervous system therapies. He added that the new approval for bipolar I disorder underscores the successful collaboration between Teva and Medincell and their shared goal of improving patient care.

The FDA’s approval for the treatment of bipolar I disorder was based on prior safety and efficacy data from previously approved risperidone formulations, as well as findings from two Phase 3 pivotal studies of UZEDY in schizophrenia: the RISE Study (TV46000-CNS-30072) and the SHINE Study (TV46000-CNS-30078). These studies demonstrated the long-term safety, tolerability, and effectiveness of the extended-release formulation, supporting its expanded use for patients with bipolar I disorder.