FDA Accepts sNDA for Risperidone Extended-Release Injectable Suspension for Bipolar I Disorder

Credit: FDA

Teva Pharmaceuticals and Medincell announced on February 25, 2025, that the US Food and Drug Administration (FDA) accepted their supplemental new drug application (sNDA) for risperidone (UZEDY) extended-release injectable suspension to treat adults with bipolar I disorder.¹

The sNDA is based on existing data on UZEDY, as well as previous findings of the safety and efficacy of previous risperidone formulations approved for bipolar I disorder.

“Since the FDA approval of UZEDY almost two years ago, it has proven to be an important treatment option for people living with schizophrenia,” said Eric Hughes, MD, PhD, executive vice president of Global R&D and Chief Medical Officer at Teva, in a press release. “Today’s filing demonstrates the potential of UZEDY’s clinical profile as a long-acting treatment for bipolar-I, a complex mental health disorder that significantly affects a person’s mood, behavior, and overall state of mind.”

The FDA approved UZEDY for the treatment of schizophrenia in 2023. UZEDY administers risperidone via copolymer technology under license from Medincell that allows for absorption and sustained release after the injection.² The approval of UZEDY was based on the promising efficacy and long-term safety data of 2 phase 3 trials: RISE and SHINE.¹

RISE, a randomized, multicenter, double-blind, placebo-controlled phase 3 trial evaluated the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients aged 13 – 65 years with schizophrenia. Participants (n = 544) were randomized 1:1:1 to receive UZEDY once monthly, once every 2 months, or a placebo. The primary endpoint was time to relapse.

SHINE evaluated the long-term safety, tolerability, and effect of UZEDY administered once monthly or every 2 months up to 56 weeks in 331 patients aged 13 – 65 years with schizophrenia. The primary endpoint was the frequency of all adverse events. Common adverse events of risperidone included tremors, sedation, dizziness, anxiety, blurred vision, nausea, upper abdominal pain, increased appetite, fatigue, rash, nasal congestion, and upper respiratory tract infection, among others.

“Long-acting injectables are key drivers of innovation in the CNS field today,” said Richard Malamut, Chief Medical Officer at Medincell, in a statement. “In bipolar I disorder, as in schizophrenia, nonadherence remains a major barrier to effective care, one that UZEDY has the potential to help.”

Studies have yet to evaluate the safety and efficacy of UZEDY for bipolar I disorder.

References

1. Teva and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder. Business Wire. February 25, 2025. https://www.businesswire.com/news/home/20250225269757/en/Teva-and-Medincell-Announce-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-UZEDY%C2%AE-risperidone-Extended-Release-Injectable-Suspension-as-a-Treatment-for-Patients-with-Bipolar-I-Disorder. Accessed February 26, 2025.

2. Walter, K. FDA Approves Risperidone for Adults with Schizophrenia. HCPLive. May 1, 2023. https://www.hcplive.com/view/fda-approves-risperidone-adults-schizophrenia. Accessed February 26, 2025.