The COVID-19 pandemic has exacerbated mental health issues and is triggering new conditions for people already suffering from mental illnesses and substance abuse.
Social anxiety disorder (SAD) is one of the most prevalent mental health conditions in the U.S., affecting 20 million Americans. The current standard of care includes antidepressants, benzodiazepines, and/or beta-blockers, which can lead to addiction and side effects of dangerous drug interactions — and they commonly have a slow onset factor. In fact, Benzos were recently the subject of a U.S. Food and Drug Administration (FDA) Drug Safety Communication (DSC) which detailed the risks associated with their abuse, misuse and overuse.
Enter VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety and depression. The company’s innovative PH94B nasal spray is expected to soon enter Phase 3 development for the acute treatment of anxiety in adults with SAD. In Phase 2 clinical studies, PH94B demonstrated s promising rapid-onset anti-anxiety effects (within about 15 minutes) without any notable side effects or safety concerns.
Here’s what you need to know.
The VistaGen Approach - PH94B Nasal Spray
VistaGen’s PH94B - an investigational, odorless pherine nasal spray - leads to rapid suppression of anxiety levels. With its novel mechanism of pharmacological action, rapid-onset of therapeutic effects and favorable safety and tolerability profile shown in all clinical studies to date, PH94B has the potential to become the first FDA-approved acute treatment of anxiety in adults with SAD.
Self-administered in microgram-level doses, in Phase 2 clinical studies, PH94B produced rapid-onset antianxiety effects within approximately 15 minutes of administration, without the troubling side effects associated with benzodiazepines.
PH94B’s mechanism of action is designed to be differentiated from the mechanism of action of all benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators, as well as all antidepressants and beta blockers used to treat SAD and other anxiety disorders.
Key results in its recent ADAA poster presentation include the following:
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PH94B had no significant effect on GABA potentiation at doses up to 10 micromolar, compared to the 300% potentiation induced by diazepam, a commonly prescribed benzodiazepine.
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The concentration of PH94B that gives the half-maximal response (EC50) could not be calculated for PH94B, whereas diazepam’s half-maximal response (EC50) was 72 nanomolar.
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PH94B had no agonist or antagonist effects on GABA receptors compared to the effect of GABA (EC50= 4.7 micromolar) and bicuculline (EC50= 1.6 micromolar), respectively.
VistaGen Pipeline
Apart from its innovative PH94B, VistaGen is developing two other solutions for unmet needs in mental health, each with a novel mechanism of action, favorable safety results in all studies to date, and therapeutic potential in multiple large therapeutic indications.
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PH10 nasal spray for depression disorders: Designed to not require systemic uptake or distribution with the goal of producing ketamine-like rapid-onset antidepressant effects without the significant side effects and safety concerns associated with ketamine-based therapy.
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AV-101, an oral prodrug of 7-Cl-KYNA, for depression and neurological disorders: Designed to inhibit (but not block) NMDA receptor activity.
Corporate Highlights
The novel mechanisms of action of the drug candidates in VistaGen’s pipeline are fundamentally different from conventional approaches. Each has favorable safety results in all clinical studies to date and therapeutic potential in several large global mental health or neurology markets. For more details, click here.
The following article is sponsored by VistaGen Therapeutics, Inc. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
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