Vistagen to Present Exploratory Safety and Efficacy Data for Fasedienol (PH94B) from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

Last Hour Poster Presentation Highlights Data on Long-Term Open-Label Treatment of As-Needed Intranasal Phasedienol Administrations in a Real-World Setting

SOUTH SAN FRANCISCO, California, May 30, 2023–(BUSINESS WIRE)–Vistagen (Nasdaq: VTGN), an advanced clinical-stage biopharmaceutical company aiming to transform the treatment landscape for people living with anxiety, depression, and other central nervous system (CNS) disorders, today announced that safety and exploratory efficacy data from its open-label Phase 3 study of Fasedienol Nasal Spray (PH94B) for the treatment of adults with social anxiety disorder (SAD) will be presented in a groundbreaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) Annual Meeting 2023 to be held in Miami from May 30 to June 2, 2023.

Poster Session I: Wednesday, May 31, 2023, 11:15am to 1:00pm Eastern Time
Title: A Phase 3 Open Label Safety Study of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults With Social Anxiety Disorder (SAD)
Poster number: W74

The poster will be available at after the conference concludes.

About Phasedienol (PH94B)

Vistagens Fasedienol (PH94B) is an experimental, first-of-its-class ferine nasal spray with a novel proposed mechanism of action (MOA) that regulates the olfactory-amygdala neural circuits of fear and anxiety and tone down the system sympathetic autonomic nervous system, without systemic distribution, GABA-A receptor enhancement, or direct activity on neurons in the brain. Vistagen is developing phasedienol in a Phase 3 program for the treatment of social anxiety disorder. Designed for intranasal administration at low microgram doses, the proposed new MOA of phasedienol is fundamentally differentiated from all currently approved anti-anxiety drugs, including all antidepressants and benzodiazepines.

Learn about social anxiety disorder

Social anxiety disorder (SAD) affects an estimated 25 million Americans. A person with SAD experiences intense and persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, making comments in a business meeting, dating, being at a job interview, answering a question in class, or talking to a cashier in a shop. Doing common, everyday things in front of people causes deep anxiety or fear of being embarrassed, evaluated, humiliated, judged, or rejected. SAD can get in the way of getting to work, attending school, or doing a wide variety of things in a situation that might involve interpersonal interaction. It can lead to evasion and opportunity costs which can have a significant impact on a person’s employment and social activities and can be very detrimental to their overall quality of life. SAD is commonly treated long-term with some FDA-approved antidepressants, which have a slow onset of effect (several weeks) and provide limited therapeutic benefit, and with benzodiazepines, which are not FDA-approved for the treatment of SAD. Both antidepressants and benzodiazepines have known side effects and significant safety concerns that can make them unattractive to people with SAD.

About Vistagen

Vistagen (Nasdaq: VTGN) is an advanced clinical-stage biopharmaceutical company aiming to transform the treatment landscape for people living with anxiety, depression and other central nervous system disorders. Vistagen is making therapeutic advances with the potential to act faster and with fewer side effects and safety concerns than currently available for the treatment of anxiety, depression and multiple CNS disorders. The Vistagens pipeline includes six clinical-stage product candidates, including five investigational agents from a new drug class known as ferines, as well as AV-101, an oral N-methyl-D-receptor glycine site antagonist aspartate (NMDAR). Ferins, which are administered as nasal sprays, are designed with an innovative rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can selectively and beneficially impact key neural circuits in the brain without requiring systemic absorption or the activity directed on the neurons of the CNS. Vistagens AV-101 inhibits NMDAR ion channel activity but does not block it. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and many other central nervous system disorders. Connect at

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Mark McPartland
Senior Vice President, Investor Relations
(650) 577-3606

Nate Hitching
SKD extension

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