Teva Pharmaceuticals and Medincell announced on October 10, 2025, the U.S. FDA’s approval of an expanded indication for UZEDY® (risperidone) extended-release injectable suspension, now authorized for subcutaneous use as monotherapy or adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder (BD-I) in adults. This marks UZEDY’s second major indication following its 2023 approval for schizophrenia treatment in adults, where it is administered every one or two months.
The approval relies on established clinical data from prior risperidone formulations approved for BD-I, integrated with Model-Informed Drug Development (MIDD) approaches. These methodologies incorporate safety and efficacy findings from UZEDY’s pivotal Phase 3 trials for schizophrenia: the RISE Study (TV46000-CNS-30072) and SHINE Study (TV46000-CNS-30078), which demonstrated reduced relapse risk, long-term tolerability, and steady pharmacokinetic profiles. UZEDY employs Medincell’s proprietary SteadyTeq™ copolymer technology (licensed from BEPO®), enabling rapid therapeutic risperidone levels within 6-24 hours post-injection and sustained release over a month, fully bioresorbable and administered subcutaneously.
BD-I affects approximately 1% of U.S. adults lifetime (over 3.4 million individuals), characterized by manic and depressive episodes disrupting daily life, often comorbid with other psychiatric conditions. It correlates with poor outcomes, including elevated mortality from suicide and cardiovascular disease. Treatment adherence remains a barrier with daily oral antipsych RSNs, making long-acting injectables like UZEDY valuable for stabilizing mood and reducing relapse. For BD-I, dosing options include 50 mg, 75 mg, or 100 mg monthly. Common side effects mirror those in schizophrenia trials: weight gain, movement disorders (e.g., stiffness, shaking), drowsiness, and injection-site reactions. Serious risks include neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes (hyperglycemia, dyslipidemia), and cerebrovascular events in elderly patients. UZEDY is contraindicated in dementia-related psychosis due to mortality risks.
Clinicians like Dr. Craig Chepke highlight its potential to bridge care gaps. Teva emphasizes this as advancing neuroscience innovation, while Medincell underscores long-acting formulations’ role in CNS therapeutics. Prescribing information warns of prolactin elevation, orthostatic hypotension, and pregnancy risks (third-trimester exposure may cause neonatal issues; registry monitoring advised). Patients should report side effects to FDA. This milestone reinforces Teva’s Pivot to Growth strategy, enhancing access to innovative mental health solutions amid global burdens.
