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VistaGen Therapeutics’ (NASDAQ: VTGN) New Generation Phase 3 Drug Candidate for Social Anxiety Disorder Gains Importance Amid FDA Wariness of Benzodiazepines
November 5, 2020

VistaGen Therapeutics’ (NASDAQ: VTGN) New Generation Phase 3 Drug Candidate for Social Anxiety Disorder Gains Importance Amid FDA Wariness of Benzodiazepines

  • VistaGen has three innovative CNS drug candidates which target a wide range of anxiety, depression and neurological disorders
  • PH94B, the Company’s most advanced drug candidate, is entering Phase 3 development for acute, on-demand treatment of social anxiety disorder
  • Company sees potential to displace benzodiazepines currently being used to treat multiple anxiety disorders
  • Strategy has gained in importance after U.S. FDA announced in late-September its update requirement for boxed warnings on all benzodiazepines to highlight risks of abuse, misuse, addiction, and physical dependence
  • Benzodiazepine epidemic is as worrisome as the opioid epidemic – 92 million benzodiazepine prescriptions in 2019 according to the FDA 

VistaGen Therapeutics (NASDAQ: VTGN) is a biopharmaceutical company committed to developing a new generation of medications which go beyond the standard of care for anxiety, depression, and several neurological disorders. The company’s product portfolio consists of three novel drug candidates which seek to target a wide variety of central nervous system (“CNS”) disorders through medications with potential to not only be effective but also present fewer side-effects and safety concerns relative to the current standard of care. Its initiative relating to anxiety disorders has unique potential to pay dividends following recent actions taken by the U.S. Food and Drug Administration (“FDA”) involving benzodiazepines, a class of drugs widely used to treat anxiety disorders, as well as insomnia and seizures.

In late September 2020, the FDA announced that it would require the boxed warning on all benzodiazepines to be updated to describe the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions consistent to all medicines in this class (https://ibn.fm/sHdvF).   

A review carried out by the FDA found that benzodiazepines were widely prescribed in the U.S., with 92 million prescriptions in 2019, often for extended periods of time. The study also found that benzodiazepines were widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs—all of which could result in serious issues. Separately, the FDA study also revealed that some patients were found to have suffered serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose reduced quickly, with a significant minority experiencing difficult withdrawal symptoms for several months. 

With its lead drug candidate, PH94B, entering Phase 3 development in 2021, VistaGen Therapeutics is focused on displacing benzodiazepines in the treatment paradigm for the acute treatment of social anxiety disorder, as well as many other anxiety disorders. 

The global CNS therapeutics market is estimated to reach $130 billion by 2025 and has been forecast to grow at a CAGR of more than 5.93% between 2018-2025. A rise in mental illnesses and increased awareness of psychiatric disorders (https://ibn.fm/I0JiR), conditions which have been exacerbated during the COVID-19 pandemic, have been calculated to cost the global economy an estimated $1 trillion each year. The impact of these conditions is particularly devastating among the young. Industry data suggest that approximately 20% of the world’s children and teens are affected by mental health conditions, and suicide is the leading cause of death among 15- to 29-year-olds (https://ibn.fm/53t2R). 

The impact of mental health disorders on patient lives and the wider global economy, coupled with the potential risks associated to conventional benzodiazepine drugs, have increased the urgent need for pharmaceutical companies to develop more effective and safer alternatives to the current standard of care available to patients today. As such, VistaGen has taken it upon itself to help address the millions of underserved patients suffering from anxiety and depression disorders whose current treatments are either inadequate or generate debilitating side effects and serious safety concerns, including risk of abuse and death.

“Now more than ever, the new generation anti-anxiety and antidepressant medications we are developing at VistaGen – PH94B, PH10 and AV-101 – are relevant, necessary and demand the highly-focused and passionate efforts of our team and partners, with the support of our stockholders, to advance them to patients whose lives are disrupted by anxiety and depression disorders,” VistaGen CEO and Director Shawn K. Singh said in his closing remarks at the company’s 2020 Annual Meeting of stockholders (https://ibn.fm/UyTmK).     

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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