//

The Future of Healthcare: “Let’s focus on a new generation of treatment options for major depressive disorder, social anxiety disorder and suicidal ideation.”

Depression is a serious affliction that affects over 300 million people worldwide. In the U.S., one in eight Americans over age 12 takes an antidepressant. Two-thirds of those who elect to take a current antidepressant do not respond to their initial treatment. Depression is often associated with both anxiety and suicide. We need better treatments, […]

Depression is a serious affliction that affects over 300 million people worldwide. In the U.S., one in eight Americans over age 12 takes an antidepressant. Two-thirds of those who elect to take a current antidepressant do not respond to their initial treatment. Depression is often associated with both anxiety and suicide. We need better treatments, combined with greater awareness and societal acceptance of depression as a disease — a disease to be identified and tackled openly, directly and collectively as, for example, we now embrace the challenges of breast cancer, prostate cancer and many other diseases which in years past were not often discussed openly for various social reasons. If patients are presented with medicine that works faster, more often, with fewer side effects, and a convenient at-home use capability, compliance will improve and lives will change. When lives change, the world changes.


Ihad the pleasure to interview Shawn Singh. Shawn is the CEO of VistaGen Therapeutics (NASDAQ: VTGN), and has over 25 years of experience working with both private and public biotech, medical device and pharmaceutical companies, a healthcare venture capital firm, and a contract research and development organization (CRO), serving in numerous senior management roles. By focusing VistaGen, a clinical-stage biopharma company, on developing new generation medicines for mental health disorders with high unmet need, Shawn and his team are committed to creating a more hopeful future for millions of people worldwide suffering from depression, social anxiety and suicide.


Thank you so much for joining us! Can you tell us about your “Big Idea That Might Change the World”?

Current treatments for depression, social anxiety and suicidal ideation (suicidal thoughts and behaviors) fall far short of the needs of millions battling these formidable mental health challenges around the world every day. Current medications take too long to work, don’t work often enough or long enough, and usually have significant side effects and safety concerns. Current treatment paradigms have to change. Too many people, both patients and their extended support systems, are suffering, every day. My “Big Idea That Might Change the World” is to focus development on a new generation of treatment options that are fundamentally different from all current treatments — concentrating on three major mental health problems that affect millions worldwide — major depressive disorder (MDD), social anxiety disorder (SAD), and suicidal ideation (SI). Imagine a country — a world — in which millions suddenly become more caring, innovative and productive — millions whose lives are transformed by new generation medicine that gives them a newfound ability to manage their lives and their mental health challenges safely, at home (not in a clinical setting) and without side effects or safety concerns often associated with current medicine for neuropsychiatry disorders. At VistaGen, we are working to make this idea a reality through passionate commitment to advancing development on our three new generation drug candidates, each of which we believe have life-changing potential.

Tapping into ketamine’s fast-acting antidepressant efficacy, VistaGen’s drug candidate, AV-101, is mechanistically similar to ketamine (engaging the NMDA receptor) but chemically different and administered orally with potential for at-home convenience due to its exceptional safety profile. Following the FDA’s recent milestone approval of Johnson & Johnson’s Spravato (esketamine) nasal spray, VistaGen’s AV-101 has the potential to deliver even more exciting new hope for patients as another new generation treatment, with fast-onset ketamine-like antidepressant benefits (without ketamine’s well-known psychological side effects and safety concerns) — and the added benefit of patient convenience, with oral administration and at-home use potential. Because there is no “one size fits all” or “one and done” treatment for depression, we are similarly excited about PH10, a novel neuroactive nasal spray for MDD. PH10’s unique mechanism of action activates nasal chemosensory receptors that trigger neural circuits and impulses in the brain leading to antidepressant effects. We believe patients should have as many safe and effective treatment options as possible, whether it’s IV ketamine, esketamine nasal spray, AV-101, PH10, or any other new generation medication in development. We want as many people as possible to change from hopeless to hopeful as soon as possible. Fortunately, we have seen some amazing developments in the field in recent years and are confident that further game-changing advances are on the horizon.

Social anxiety disorder (SAD) is another very serious and widespread mental health problem. We believe we are on the leading edge of pharmaceutical development in this area, with a late-stage drug candidate, PH94B, with the potential to transform the current treatment paradigm for SAD, a paradigm that has not seen advances in over a decade. As are AV-101 and PH10 for MDD, PH94B is fundamentally different from all current therapies for SAD. PH94B is a first-in-class neuroactive nasal spray in late-stage (entering pivotal Phase 3) clinical development for on-demand, as-needed treatment of SAD prior to a fear- or anxiety-provoking social event or situation. Because social anxiety has a situational onset, an as-needed treatment option with fast onset therapeutic activity can potentially give the millions who suffer from SAD the ability to engage in the common, everyday social and performance situations that they often avoid due to their intense anxiety and fear of being judged, humiliated, negatively evaluated, or rejected — the common hallmarks of SAD.

How do you think this will change the world?

Depression is a serious affliction that affects over 300 million people worldwide. In the U.S., one in eight Americans over age 12 takes an antidepressant. Two-thirds of those who elect to take a current antidepressant do not respond to their initial treatment. Depression is often associated with both anxiety and suicide. We need better treatments, combined with greater awareness and societal acceptance of depression as a disease — a disease to be identified and tackled openly, directly and collectively as, for example, we now embrace the challenges of breast cancer, prostate cancer and many other diseases which in years past were not often discussed openly for various social reasons. If patients are presented with medicine that works faster, more often, with fewer side effects, and a convenient at-home use capability, compliance will improve and lives will change. When lives change, the world changes.

Similarly, SAD is prevalent with about 7% of U.S. adults and 9% of U.S. adolescents affected. SAD can really wreak havoc on the lives of those who suffer from it daily. Symptoms may be so extreme as to disrupt daily functioning, interfering with daily routines, job performance, or social lives. Also, as noted, individuals with SAD are also at an increased risk for developing MDD and alcohol use or other substance abuse disorders.

Finding effective, on-demand, as-needed treatments can restore the daily functioning and improve the quality of life for millions of individuals. People’s lives can be changed for the better in more than one way with promising new drugs like those VistaGen is developing.

What do you need to lead this idea to widespread adoption?

As with most Big Ideas, time and prudent capital support from long-biased investors are key. In addition, successful outcomes in FDA-required clinical trials are essential. After our drug candidates progress through FDA-required clinical trials, we will need to receive the FDA’s market approval. That will enable us to make our new generation treatments available to doctors and patients.

How can our readers follow you on social media?

You can follow @VistaGen on Twitter and Facebook to see what’s happening with our new generation CNS pipeline as we continue to advance our efforts to execute our Big Idea to Change the World.

Share your comments below. Please read our commenting guidelines before posting. If you have a concern about a comment, report it here.

You might also like...

Community//

How voice recognition technologies can save young adults’ lives

by Ivan Tiutiundzhi
Well-Being//

An Expert Answers Your Questions on Depression for World Health Day

by Thrive Global
Community//

Depression, Anxiety May Take Same Toll on Health as Smoking and Obesity

by Andrea Niles, Aoife O'Donovan

Sign up for the Thrive Global newsletter

Will be used in accordance with our privacy policy.

Thrive Global
People look for retreats for themselves, in the country, by the coast, or in the hills . . . There is nowhere that a person can find a more peaceful and trouble-free retreat than in his own mind. . . . So constantly give yourself this retreat, and renew yourself.

- MARCUS AURELIUS

We use cookies on our site to give you the best experience possible. By continuing to browse the site, you agree to this use. For more information on how we use cookies, see our Privacy Policy.