Ketamine has been shown as
an extremely effective treatment for patients suffering from major depressive
disorder (MDD). Unfortunately, its prospects for widespread therapeutic use are
exceptionally limited because of its high potential for abuse, dissociative and
psychosis-like side effects, and required intravenous administration in a
medical center.
VistaGen Therapeutics,
Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company, is currently
collaborating with Dr. Carlos Zarate and the U.S. National Institutes Health
(NIH) on an NIH-funded Phase 2 clinical study of its new drug candidate,
AV-101, for the treatment of MDD.
The industry is buzzing
about AV-101, which is orally-active, because it may rapid-acting
antidepressant benefits that are extremely similar to intravenous ketamine,
without ketamine’s limiting side effects. “We are excited by the strong
preclinical efficacy data supporting the ketamine-like antidepressant effects
of AV-101, as well as the rapid and efficient oral-delivery and clinical safety
range demonstrated by our successful Phase I clinical studies,” said H. Ralph
Snodgrass, President and CSO of VistaGen. The company expects to complete its
Phase 2 study by the end of this year.
While current MDD
medications are part of a multi-billion dollar global antidepressant market,
the available treatments have limited effectiveness in many cases. Although two
out of three patients eventually find a drug combination that induces remission
of their depression symptoms, the trial and error process that is presently in
use is known to increase the risks of patient tolerability issues and serious
side effects. Sadly, as many as 15 percent of individuals suffering with MDD
commit suicide as a result.
AV-101’s mechanism of
action is fundamentally different compared to current MDD medications. AV-101
works by modulating NMDA receptor channel activity by selectively binding to,
and blocking, the glycine-binding co-agonist site of the NMDA receptor. By targeting
the glycine-binding co-agonist site, the company’s drug candidate can bypass
the adverse effects associated with ketamine without eliminating its surge of
glutamate, which provides a powerful antidepressant effect to the patient.
VistaGen’s AV-101 could prove to be the perfect solution to correct the flaws
in the current treatment process.
MDD is a widespread and
debilitating mental disorder affecting nearly 7 percent of U.S. adults.
VistaGen, through its AV-101, could be on the brink of a breakthrough for MDD
patients who do not benefit from existing antidepressants.
For more information on
the company, visit www.vistagen.com
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