FDA OKs Once Monthly Subcutaneous Risperidone for Bipolar I Disorder
The US Food and Drug Administration (FDA) has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension for the treatment of bipolar I disorder (BD-I), announced manufacturer Teva Pharmaceuticals on October 10, 2025.
The drug had been previously approved as a treatment for schizophrenia in adults in 2023.
Risperidone may be used as monotherapy or as adjunctive treatment to lithium or valproate in adults with BD-I for the management of new mood episodes. The injectable is available in 3 once-monthly dosages: 50 mg, 75 mg, and 100 mg. It is estimated that therapeutic blood concentrations are achieved within 6 to 24 hours following administration of a single dose.
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“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, 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.”
The FDA’s approval for risperidone was informed by previous findings of safety and efficacy of past formulations approved for the treatment of BD-I. Additionally, the efficacy, long-term safety, and tolerability data of the drug for use in schizophrenia were taken into consideration, as evaluated in 2 Phase 3 studies: the RISE study and the SHINE study.
Risperidone is not approved for use in patients with dementia-related psychosis. It can also cause serious side effects, including stroke in elderly people, neuroleptic malignant syndrome, tardive dyskinesia, metabolism problems, high levels of prolactin in blood, and seizures.
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