FDA Accepts Supplemental New Drug Application for Teva, Medincell’s Uzedy for Bipolar I Disorder

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The FDA has accepted a supplemental New Drug Application (sNDA) from Teva Pharmaceuticals and Medincell for Udezy (risperidone) extended-release injectable suspension as a maintenance treatment for adults with bipolar I disorder (BP-I). According to Teva, the application is based on existing clinical data for the treatment as well as prior FDA findings on the safety and efficacy of risperidone treating BP-I. The safety and tolerability of Udezy was evaluated in the pivotal Phase III RISE and SHINE trials.¹

“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, EVP, global R&D, chief medical officer, 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. Debilitating manic and depressive symptoms and signs can also occur.”

The multicenter, randomized, double-blind, placebo-controlled RISE trial evaluated the efficacy of Uzedy in patients between 13 and 65 years of age with schizophrenia. The primary endpoint of the study was time to impending relapse. A total of 544 patients were randomly assigned in a 1:1:1 to receive a subcutaneous injection either once a month, once every two months, or placebo.

SHINE evaluated the long-term safety, tolerability and effect of subcutaneously administered Udezy in 331 patients with schizophrenia for up to 56 weeks. The primary endpoint of the trial was the frequency of all adverse events (AEs).

Teva warns that in patients with dementia-related psychosis, there is a higher risk of cerebrovascular AEs, including stroke and transient ischemic attack. More common AEs included parkinsonism; akathisia; dystonia; tremor; sedation; dizziness; anxiety; blurred vision; nausea; vomiting; upper abdominal pain; stomach discomfort; dyspepsia; diarrhea; salivary hypersecretion; constipation; dry mouth; increased appetite; increased weight; fatigue; rash; nasal congestion; upper respiratory tract infection; nasopharyngitis; and pharyngolaryngeal pain.¹

According to the World Health Organization, an estimated 40 million people are currently living with bipolar disorder, equal to 0.53% of the global population. While prevalence between men and women is nearly equal, data has shown that women are diagnosed more often.²

According to the National Institute of Health and Medicine, approximately 2.8% of adults in the United States were living with bipolar disorder within the past year and 4.4% of all adults in the United States develop the condition at some point during their lifetime. Further, 82.9% had a serious impairment as a result, while 17.1% had moderate impairment. In adolescents, 2.9% had bipolar disorder, while 2.6% had severe impairment as a result. In adolescent females, the rate was 3.3% compared to 2.6% for males.³

“Long acting injectables are key drivers of innovation in the CNS field today,” said Richard Malamut, chief medical officer, Medincell, 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.”

Moving forward, Teva is expected to lead both the regulatory process and commercialization efforts, with Medincell receiving net sale royalties. Currently, Udezy is not approved for BP-I by any regulatory authority.¹

References

1. Teva and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY(R) (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder. Teva. February 25, 2025. Accessed February 26, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-and-medincell-announce-fda-acceptance-of-supplemental-new-drug-application-for-uzedyr-risperidone/

2. Bipolar disorder. WHO. Accessed February 26, 2025. https://www.who.int/news-room/fact-sheets/detail/bipolar-disorder

3. Bipolar Disorder. NIH. Accessed February 26, 2025. https://www.nimh.nih.gov/health/statistics/bipolar-disorder