FDA Approves Expanded Indication for Risperidone Extended-Release Injectable to Treat Bipolar I Disorder

The FDA approved risperidone (Uzedy; Teva Pharmaceuticals), a once-monthly extended-release injectable suspension, as either a monotherapy or an adjunctive therapy to lithium or valproate as a maintenance treatment in adults with bipolar I disorder. The approval is based on existing clinical data for the extended-release injectable suspension coupled with model-informed drug development methodologies that leverage previous findings on the formulation’s safety and efficacy for bipolar I disorder, according to a news release from the manufacturer.¹

Risperidone extended-release injectable suspension is indicated for subcutaneous use in adults with schizophrenia and as a monotherapy or adjunctive therapy for the maintenance treatment of adults with bipolar I disorder. The extended-release formulation administers risperidone through copolymer technology that allows for rapid absorption and sustained release after subcutaneous injection. In clinical trials, the formulation significantly reduced the risk of schizophrenia relapse.¹

The treatment is the only long-acting, subcutaneous formulation of risperidone available in both 1- and 2-month dosing intervals, according to the manufacturers. Therapeutic blood concentrations are reached within 6 to 24 hours of a single dose. For the bipolar I disorder indication, the extended-release injectable suspension is now approved with 3 once-monthly dosing options (50 mg, 75 mg, and 100 mg).¹

“Adults living with [bipolar I disorder] 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,” Chris Fox, executive vice president of US Commercial at Teva, said in a news release. “This expanded indication for Uzedy builds on its success in adults living with schizophrenia and demonstrates [our] dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”¹

Risperidone's antidepressant effects are believed to involve serotonin and norepinephrine reuptake inhibition, according to experts. Positive symptoms may be a result of the blockade of D2 receptors in the mesolimbic pathway. The ability of antipsychotics to block D2 receptors in the prefrontal cortex and nucleus accumbens is essential in improving various psychiatric symptoms. Further, risperidone is also used off-label to treat borderline personality disorder, delirium, depression, posttraumatic stress injury, Tourette syndrome, and other developmental and mental disorders.

Along with psychotic symptoms, risperidone is also prescribed to treat aggression and agitation in patients with dementia; to augment antidepressant therapy for patients with nonpsychotic unipolar depression; and for social impairment, stereotypical behaviors, cognitive problems, and hyperactivity in patients with autism.¹

“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,” Craig Chepke, MD, DFAPA, medical director of Excel Psychiatric Associates and scientific director, HMP Global’s Psych Congress events and programs, said in the news release. “The FDA’s decision to expand the indication for Uzedy may help those living with [bipolar I disorder]. As a clinician, I am excited to now have a new treatment option for this complex disease.”¹

The most common adverse events reported by patients in clinical trials receiving treatment with risperidone extended-release injectable suspension were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth.²

“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” Christophe Douat, CEO of Medincell, said in the news release. “We’re proud that Uzedy is now available to support patients living with bipolar I disorder.”¹

REFERENCES

1. Teva Pharmaceuticals. FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder. News release. October 10, 2025. Accessed October 10, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-uzedy-risperidone-extended-release-injectable-suspension-as-a-tre/

2. McGovern G. Amneal’s Injectable Extended-Release Suspension of Risperidone Receives FDA Approval to Treat Schizophrenia. Pharmacy Times. September 4, 2025. Accessed October 10, 2025. https://www.pharmacytimes.com/view/amneal-s-injectable-extended-release-suspension-of-risperidone-receives-fda-approval-to-treat-schizophrenia