FDA grants VistaGen ‘Fast Track’ designation for PH10 development to treat MDD

Vistagen announced the U.S. Food and Drug Administration FDA has granted Fast Track designation for the development of PH10, one of the Company’s investigational nasal sprays, for the treatment of major depressive disorder MDD . The FDA’s Fast Track program facilitates the expedited development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, with the intention to bring promising new medicines to patients sooner. "Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression. The FDA’s grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10’s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed," stated Shawn Singh, Chief Executive Officer of Vistagen. "Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with a first line therapy. With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need. We look forward to working with the FDA’s Fast Track program as we advance development of PH10 in the United States."