VistaGen Therapeutics (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, with emphasis on major depressive disorder, neuropathic pain, Parkinson's disease LID, social anxiety disorder and suicidal ideation.
VistaGen's AV-101, an oral NMDAR GlyB antagonist, belongs to a new generation of investigational medicines in neuropsychiatry known as glutamate receptor modulators with the potential to treat major depressive disorder faster and with fewer side effects than currently available FDA-approved antidepressants which, if effective, often take many weeks to months to achieve therapeutic benefits and are associated with side effects and safety concerns. With at-home convenience of an oral therapy, AV-101 has the potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. The FDA has granted Fast Track designation to AV-101 for development as an adjunctive treatment for major depressive disorder and as a non-opioid treatment of chronic neuropathic pain.
VistaGen's PH10 and PH94B were developed from proprietary compounds called pherines. With intranasal administration, PH10 and PH94B act locally on peripheral nasal chemosensory receptors that trigger rapid activation of neural impulses in areas of the brain associated with depression (PH10) social anxiety disorder (PH94B). This mechanism of pharmacological action, the rapid onset of efficacy, and the excellent safety and tolerability profile demonstrated in clinical trials to date make PH10 and PH94B, respectively, excellent product candidates for chronic treatment of patients with depression and for on-demand (PRN) treatment of social anxiety disorder.