FDA Accepts Supplemental New Drug Application for UZEDY Injectable for Bipolar I Disorder

Teva Pharmaceuticals, a U.S. branch of Teva Pharmaceutical Industries Ltd., and Medincell have announced the acceptance of their supplemental New Drug Application (sNDA) by the U.S. Food and Drug Administration (FDA) for the use of UZEDY in the maintenance treatment of bipolar I disorder (BP-I) in adults. UZEDY is a long-acting injectable that was approved in 2023 for schizophrenia treatment. This move highlights Teva’s dedication to expanding its portfolio in neuroscience and addressing unmet medical needs for conditions such as BP-I.

The application builds on the existing clinical data for UZEDY, leveraging previous findings related to risperidone's safety and efficacy. Since UZEDY's initial approval in the U.S. for schizophrenia treatment, it has gained traction as a viable option for managing the condition. Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, emphasized UZEDY's potential to serve as an effective long-acting treatment for BP-I, a challenging mental health disorder that impacts mood and behavior significantly.

The partnership with Medincell allows Teva to spearhead the regulatory processes and potential commercialization of UZEDY for BP-I, with Medincell set to receive royalties from net sales. Dr. Richard Malamut, Chief Medical Officer at Medincell, pointed to nonadherence as a major hurdle in treating BP-I and schizophrenia, suggesting that UZEDY's long-acting formulation could enhance adherence and improve treatment outcomes.

The efficacy and safety profile of UZEDY in treating schizophrenia was established through two Phase 3 studies: the RISE Study and the SHINE Study. The RISE Study was a randomized, double-blind, placebo-controlled trial that evaluated the effectiveness of risperidone extended-release injectable suspension in preventing relapse in patients with schizophrenia. The study involved 544 participants and compared monthly and bi-monthly administrations of UZEDY against a placebo. The primary goal was to measure the time to impending relapse.

The SHINE Study focused on assessing the long-term safety and tolerability of UZEDY over 56 weeks in 331 schizophrenia patients. The primary endpoint for this study was the frequency of adverse events, both minor and serious. While UZEDY is currently approved for schizophrenia, its safety and efficacy for BP-I remain under review, as it has not yet been approved for this indication.

Bipolar I disorder is a severe mental health condition characterized by drastic mood swings that can hinder daily functioning. It is often accompanied by other psychiatric issues and poses a higher mortality risk due to suicide and cardiovascular diseases. Approximately 1% of U.S. adults are expected to develop BP-I during their lifetime.

UZEDY utilizes copolymer technology licensed from Medincell, which facilitates the absorption and sustained release of risperidone following subcutaneous injection. It is the only long-acting, subcutaneous formulation of risperidone available in one- or two-month dosing intervals, making it a convenient option for patients who require less frequent administrations. This unique formulation may address the challenges associated with nonadherence, a common issue in treating chronic mental health disorders.

In summary, Teva and Medincell's push for FDA approval of UZEDY for BP-I treatment underscores their commitment to advancing treatment options in the central nervous system (CNS) realm. By expanding UZEDY's indications, the companies hope to provide better solutions for managing BP-I, ultimately improving patient outcomes and quality of life.