Vanda Pharmaceuticals Inc. (VNDA) announced Monday 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.
Bysanti is a new chemical entity that belongs in the class of atypical antipsychotic drugs. It 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.
If 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.
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