VTGN - VistaGen AffaMed plan to start global study of nasal spray PH94B for anxiety in H2

VistaGen Therapeutics (NASDAQ:VTGN) and AffaMed Therapeutics said they have completed regulatory preparations to begin a phase 3 trial of VistaGen’s nasal spray PH94B (AM005) for the acute treatment of anxiety in adults with social anxiety disorder (SAD), in the U.S. and China. The company said the main purpose of the Phase 3 study, dubbed PALISADE Global, is to support potential commercialization of PH94B in China and other markets outside of the U.S. The design of the PALISADE Global study is based on ongoing phase 3 trials, PALISADE-1 and PALISADE-2, of PH94B in the U.S. VistaGen said its recent submission of the PALISADE Global study protocol to the U.S. Food and Drug Administration (FDA) under its existing application for a trial of PH94B in SAD and AffaMed getting regulatory clearance of an application for a trial in China for the drug has cleared the way to begin PALISADE Global in the U.S. and China during H2 2022. The companies also

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VistaGen, AffaMed plan to start global study of nasal spray PH94B for anxiety in H2