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Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia
WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.\n\n \n \n \n \n \n \n\n \nBysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors.\nIf approved, Bysanti™ could be available for sale in the US in 2026. Exclusivity, including pending patent applications, could extend into the 2040s. Additionally, Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026.\nAbout Vanda Pharmaceuticals Inc.\nVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.\nCAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS\nVarious statements in this press release, including, but not limited to, statements regarding Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, and the anticipated timing of the availability of results from the Phase III clinical study of Bysanti™ for the treatment of MDD are \"forward-looking statements\" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's assum...