VistaGen Therapeutics (NASDAQ: VTGN) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain, marking the second Fast Track designation granted to the company since December 2017. This designation facilitates the development, and possibly accelerate the review, of drugs that fill an unmet medical need to treat serious or life-threatening conditions. “Every day in the U.S., more than 115 people die from overdosing on opioids. We have evaluated AV-101 in multiple models of serious CNS conditions, including those that cause patients to suffer from neuropathic pain, for which current treatment options are inadequate. After considering peer-reviewed data published last year in The Journal of Pain, together with published safety data from our Phase 1 program, we believe AV-101 has the potential to address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain,” VistaGen CEO Shawn Singh stated in the news release.
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VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing new generation medicines for multiple CNS diseases and disorders with high unmet need. For more information, visit the company’s website at www.VistaGen.com.
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