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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