The U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) as a once-monthly, long-acting injectable for the maintenance treatment of bipolar I disorder (BD-I) in adults, pharmaceutical companies Teva Pharmaceuticals and Medincell announced today.
Already approved for schizophrenia, UZEDY is now indicated as monotherapy or adjunctive therapy to lithium or valproate for BD-I. The approval leverages existing risperidone safety and efficacy data and incorporates Model-Informed Drug Development (MIDD) strategies.
What sets UZEDY apart is its subcutaneous delivery system and use of SteadyTeq, a proprietary technology from Medincell that ensures controlled, steady drug release, achieving therapeutic levels within 6 to 24 hours after a single injection.
With the new approval, UZEDY offers three once-monthly dosing options: 50 mg, 75 mg, and 100 mg.
“This expanded indication for UZEDY builds on its success in treating schizophrenia and represents a significant advancement for adults living with bipolar I disorder,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “It reflects our commitment to developing innovative treatments for complex mental health conditions.”
Bipolar I disorder affects an estimated 1% of U.S. adults—or over 3.4 million people—and is associated with high relapse rates, reduced life expectancy, and challenges with treatment adherence, especially with daily oral medications.
“The FDA’s decision offers a valuable new option for improving adherence in a condition where long-term outcomes are often poor,” said Dr. Craig Chepke, Medical Director at Excel Psychiatric Associates.
UZEDY was first approved in 2023 for schizophrenia and is part of a growing trend toward long-acting injectables in psychiatric care, which are seen as important tools for improving patient outcomes in central nervous system (CNS) disorders.
“This approval marks another major milestone in our collaboration with Teva,” added Christophe Douat, CEO of Medincell. “We’re proud to bring a new solution to people living with bipolar I disorder.”