> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fast Track for VistaGen Non-opioid Pain Killer
- URL: https://www.fdaweb.com/fast-track-for-vistagen-non-opioid-pain-killer/
- Published: 2018-10-03T12:00:00.000Z
- Updated: 2026-09-15T00:35:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142510

FDA has granted VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain. The investigational, orally bioavailable, small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist is designed to work without psychological or sedative side effects, the company says. AV-101 is also currently in Phase 2 clinical development for major depressive disorder (MDD). The study, [ELEVATE](https://www.globenewswire.com/Tracker?data=tm71kcdUX3VUE2GuTW7DfjQc41vVGKtqoXHhrPO64gakAZumFUrfZiV9NiEHqbwzJCWhxw43v7jLJfZioHMevevP63HLLmL%5FWlq2vlOnYTdobIxPD93Iun3eQNRwjPmT&ref=fdaweb.com), is evaluating the efficacy and safety of adjunctive use of AV-101 for MDD in individuals with an inadequate response to standard antidepressant therapy with either an FDA-approved selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor.