The Food and Drug Administration (FDA) has granted Fast Track designation to AV-101 (VistaGen Therapeutics), an investigational non-opioid treatment for neuropathic pain.

AV-101 is an orally bioavailable, small molecule N-methyl-D-aspartate (NMDA) receptor glycine B antagonist. According to the Company, AV-101 has the potential to achieve ketamine-like antidepressant effects, but without the side effects and safety concerns. The treatment is currently being evaluated in a Phase 2 study (ELEVATE) in patients with major depressive disorder who have had an inadequate response to standard antidepressant therapy (ie, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors).  

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“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,” said Shawn Singh, Chief Executive Officer of VistaGen. “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.”

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