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VistaGen and AffaMed Complete Key Regulatory Submissions for PALISADE Global Phase 3 Clinical Trial for PH94B
Companies plan to initiate the global study of PH94B for the acute treatment of social anxiety disorder (SAD) in the second half of 2022 Trial designed to
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nCompanies plan to initiate the global study of PH94B for the acute treatment of social anxiety disorder (SAD) in the second half of 2022\n\nTrial designed to support commercialization of PH94B in China and other markets outside the U.S.\n\n SOUTH SAN FRANCISCO, Calif. & SHANGHAI--(BUSINESS WIRE)--\nVistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen) and AffaMed Therapeutics (AffaMed) today announced they have completed regulatory preparations to initiate PALISADE Global, a Phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen’s PH94B (referred to by AffaMed as AM005) for the acute treatment of anxiety in adults with social anxiety disorder (SAD), in the U.S. and China. The primary purpose of PALISADE Global, the design of which is based on VistaGen’s ongoing PALISADE-1 and PALISADE-2 Phase 3 clinical studies of PH94B in the U.S., is to support potential commercialization of PH94B in China and other markets outside of the U.S.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220412005206/en/\nVistaGen’s recent submission of the PALISADE Global study protocol to the U.S. Food and Drug Administration (FDA) under its existing PH94B Investigational New Drug (IND) application in SAD and AffaMed’s recent receipt of regulatory clearance of its Clinical Trial Application (CTA) from the National Medical Products Administration (NMPA) in China have cleared the way for initiation of PALISADE Global in the U.S. and China during the second half of 2022. The companies also anticipate initiating this Phase 3 study in Canada, Mexico, and South Korea. PH94B is an odorless, fast-acting neuroactive pherine nasal spray with a unique potential mechanism of action (MOA) for the acute treatment of anxiety in adults with SAD. PH94B works differently than all therapies currently approved for the treatment of SAD by either the FDA or the NMPA.\n\n“We are very pleased with the substantial progress that our teams have made toward initiating PALISADE Global in two of the world’s largest pharmaceutical markets,” said Shawn Singh, Chief Executive Officer of VistaGen. “AffaMed’s clearance from the NMPA affirms our belief that AffaMed is the right partner for PH94B in China, and we remain confident in our collaboration as we advance this important late-stage clinical...