VistaGen Stock Up 49% On Fast Track Designation For Non-opioid Pain Treatment

(RTTNews) - Shares of VistaGen Therapeutics Inc. (VTGN) are currently up 49 percent after the biopharmaceutical company said the U.S. Food and Drug Administration granted fast track status for its non-opioid pain treatment.

VistaGen, which develops new generation medicines for central nervous system diseases and disorders with high unmet need, said FDA granted fast track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain.

AV-101 is an investigational, orally bioavailable, small molecule NMDA receptor glycine B antagonist without psychological or sedative side effects.

This is the second FDA Fast Track designation granted to VistaGen since December 2017.

The FDA's Fast Track designation is designed to facilitate the development, and potentially expedite the review, of drugs to treat serious or life-threatening conditions and fill an unmet medical need.

"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 TheJournal 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," said Shawn Singh, Chief Executive Officer of VistaGen.