VistaGen Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AV-101 for development as a potential adjunctive treatment for Major Depressive Disorder (MDD). The FDA's Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as MDD. Fast Track is a process designed by the FDA to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track Designation may be eligible to be the subject of more frequent communications and meetings with FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met. The purpose is to get important new drugs to the patient earlier. Major Depressive Disorder (MDD) is a common but serious mood disorder in which individuals exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. Over 300 million people worldwide suffer from depression.1 While antidepressants are widely used for treatment, large scale studies have suggested the U.S. drug-treated MDD market is substantially underserved.2,3.