FDA Accepts Supplemental New Drug Application for Uzedy for Bipolar I Disorder

Teva Pharmaceuticals and Medincell announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for UZEDY (risperidone) extended-release injectable suspension for the maintenance treatment of bipolar I disorder (BP-I) in adults.

The sNDA submission is based on existing clinical data for UZEDY, along with previous FDA findings on the safety and efficacy of prior risperidone formulations for BP-I treatment. The agency's acceptance of the filing marks an important regulatory step in evaluating UZEDY’s potential role in the management of BP-I.

“Since the FDA approval of UZEDY almost two years ago, it has proven to be an important treatment option for people living with schizophrenia,” Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, said 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.”

Teva will oversee the regulatory process and, if approved, will be responsible for commercialization of Uzedy for BP-I. Medincell will be eligible for royalties on net sales.

“Long-acting injectables are key drivers of innovation in the CNS field today,” Richard Malamut, MD, Chief Medical Officer at Medincell, said in the press release. “In bipolar I disorder, as in schizophrenia, nonadherence remains a major barrier to effective care, one that UZEDY has the potential to help. We are proud to partner with Teva to deliver treatment options aimed at meeting unmet medical needs.”

Uzedy was initially approved in 2023 for the treatment of schizophrenia in adults. Its efficacy and long-term safety have been evaluated in two phase 3 pivotal studies: the RISE Study (TV46000-CNS-30072) and the SHINE Study (TV46000-CNS-30078).

The safety and efficacy of Uzedy for BP-I have not been established, and the formulation is not currently approved by any regulatory authority for this indication.

Reference: 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. News release. Teva Pharmaceuticals. February 25, 2025. Accessed February 27, 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