Social Anxiety Disorder (SAD)
Social anxiety disorder (SAD) affects approximately 15 million American adults and is the second most commonly diagnosed anxiety disorder. 1 SAD is characterized by excessive fear and avoidance of everyday social or performance situations in which individuals feel scrutinized or evaluated by others and fear embarrassment, humiliation and rejection. Current FDA-approved drug treatments for SAD are often of limited help to individuals, can have troubling side effects, and are not indicated for on-demand, as-needed (PRN) treatment, such as before a feared social or performance situation.
PH94B for SAD
PH94B neuroactive nasal spray is fundamentally different from all current treatments for SAD. Administered as an easy-to-use nasal spray, in microgram doses and without systemic exposure, PH94B is a synthetic neurosteroid that activates nasal chemosensory receptors that, in turn, trigger neural circuits in the brain that suppress fear and anxiety within 15 minutes. Its novel mechanism of pharmacological action, rapid-onset of therapeutic effects and exceptional safety and tolerability profile in clinical trials to date make VistaGen’s PH94B neuroactive nasal spray an excellent product candidate with potential to become the first FDA-approved PRN treatment for SAD.
Major Depressive Disorder (MDD)
According to the World Health Organization (WHO), MDD affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide. Individuals with depression, including MDD, experience continuous suffering from the serious, biologically-based disease which has a significant negative impact on all aspects of life, including quality of life. While current antidepressants are widely used for treatment, large-scale studies have suggested that the drug-treated MDD market is substantially underserved by current medications.
AV-101 for MDD
AV-101 is an oral NMDAR GlyB (N-methyl-D-aspartate receptor glycine B site) antagonist in development as a potential new treatment for MDD. AV-101’s active metabolite, 7-Cl-KYNA, is a full antagonist that inhibits NMDA receptor function rather than blocking it. We believe this difference (inhibiting NMDA receptor activity rather than blocking it), together with the activation of AMPA receptor pathways, can potentially bypass the side effects and safety concerns associated with ketamine-based therapy for MDD, while still achieving rapid-onset antidepressant effects.
The United States Food and Drug Administration has granted Fast Track designation for development of AV-101 for adjunctive treatment of MDD.
PH10 for MDD
PH10 neuroactive nasal spray is fundamentally different from all current treatments for MDD. Administered as an easy-to-use nasal spray, in microgram doses and without systemic exposure, PH10 is a synthetic neurosteroid that activates nasal chemosensory receptors that, in turn, trigger neural circuits in the brain leading to rapid-onset antidepressant effects.