VistaGen Therapeutics Inc. (NASDAQ: VTGN) Committed to Developing New Generation Alternatives to Current Standard of Care for Anxiety Disorders

• American Psychiatric Association poll reveals 62% of respondents have anxiety about COVID-19
• Recent FDA Drug Safety Communication requires updated Boxed Warning for benzodiazepines commonly used to treat anxiety disorders
• VTGN is committed to developing and commercializing PH94B, a first-in-class pherine nasal spray with potential to go beyond the current standard of care for acute treatment of social anxiety disorder and other anxiety-related disorders

Anxiety induced by the COVID-19 pandemic during the last year has been linked with surging use of benzodiazepines or “benzos,” a drug class commonly prescribed to treat anxiety and other disorders – a trend with potential to create a new wave of misuse, overuse and addiction among users while leaving physicians concerned about long-term detrimental side effects (https://ibn.fm/FFhjW). As a proactive response to what many critics are calling a “benzo epidemic” (https://ibn.fm/777mk), VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company headquartered in South San Francisco, is currently committed to developing a new generation of medicines that go beyond the current standard of care for anxiety, depression, and other central nervous system (“CNS”) disorders. VistaGen’s CNS pipeline includes multiple innovative drug candidates for treatment of anxiety and depression disorders, each of which has demonstrated favorable safety results in all clinical studies to date and significant commercialization potential in multiple neuropsychiatric markets.

Anxiety is on the rise, according to a recent poll by the American Psychiatric Association, revealing that up to 62% of respondents have serious concerns about the effects of COVID-19 on themselves or loved ones. Additionally, prescriptions for benzodiazepines spiked 34% during the early stages of the pandemic according to a study of over three million people, suggesting a link between the rise of anxiety and increased coverage of the COVID-19 issue in the media.

The use of benzodiazepines to treat anxiety has grown steadily since their discovery in the 1950s. Commonly classified as “minor tranquilizers,” benzodiazepines are prescribed to treat anxiety, panic disorders and seizures by calming nerve impulses and creating a sense of relaxation and well-being. Unfortunately, however fast-acting and highly effective they may be, benzodiazepines are also extremely addictive, earning them a Schedule IV controlled substance classification by the Drug Enforcement Agency (“DEA”) due to their potential for abuse. In September 2020, the FDA’s Drug Safety Communication (“DSC”) noted that there were 92 million prescriptions of benzodiazepines in 2019 and also detailed safety concerns regarding the serious risks of abuse, addiction, physical dependence, and withdrawal reactions linked to long-term use of benzodiazepines. As a result, in the DSC, the FDA announced that it is requiring an updated Boxed Warning, the FDA’s most prominent type of safety warning, for all benzodiazepine medications (https://ibn.fm/08UKT).

According to many medical practitioners, benzodiazepines have serious long-term consequences. Use of the drug has been associated with the development of an increased tolerance that requires higher amounts to achieve the same effect. Additional long-term consequences include addiction, future cognitive problems and incapacitating withdrawal symptoms.

VistaGen is committed to developing therapies that go beyond the limits of the current standard of care. To advance on that goal, VistaGen is currently preparing to launch Phase 3 clinical development of its PH94B for the acute treatment of anxiety in adults with social anxiety disorder (“SAD”), the third most common mental illness among Americans.  PH94B is a first in class pherine nasal spray designed with potential to deliver the rapid-onset anti-anxiety effects of benzodiazepines, but without the side effects and safety concerns associated with their use.  VistaGen currently anticipates launching its U.S. Phase 3 development program for acute treatment of SAD during the second quarter of this year.  The Company is also planning to launch exploratory Phase 2 studies in 2021 focused on several additional anxiety-related disorders, including adjustment disorder, postpartum anxiety, and pre-procedural (pre-MRI) anxiety (https://ibn.fm/bVbBy).  

For more information, visit the company’s website at www.VistaGen.com.

NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN

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