VistaGen (NASDAQ: VTGN), a biopharmaceutical company developing new generation medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (“CNS”) disorders, today announced the initiation of PALISADE-2, the second U.S. Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of PH94B for the acute treatment of anxiety in adults with social anxiety disorder (“SAD”). According to the update, PH94B is designed to be a rapid-onset, odorless pherine nasal spray with a unique potential mechanism of action for the acute treatment of anxiety in adults with SAD, working differently than all therapies approved for SAD by the U.S. Food and Drug Administration (“FDA”). “Following the successful initiation of PALISADE-1 last quarter, we are excited to be further advancing our PALISADE Phase 3 Program this quarter with the initiation of PALISADE-2, an essential next step in our efforts to further demonstrate the reduction in anxiety observed in PH94B’s Phase 2 clinical trials to date,” said Shawn Singh, CEO of VistaGen. “If successful, these Phase 3 clinical trials, along with the other planned clinical trials in our PALISADE Phase 3 Program, are intended to support the potential submission of a New Drug Application to the FDA in 2023. Our team continues to make progress towards that core objective. PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used on demand to acutely treat an asthma attack.”
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About VistaGen Therapeutics Inc.
VistaGen is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen’s drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets. For more information, please visit www.VistaGen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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