With the
very public suicide of actor/comedian Robin Williams recently, the battle with
major depressive disorder, or MDD, has moved even more into the public light.
VistaGen Therapeutics, Inc. (OTCQB: VSTA) has become one of a small group of
companies developing a new generation of antidepressant drugs to combat
depression where current antidepressants and other therapies have come up
short.
VistaGen
is slated early in the New Year to begin a Phase 2 clinical trial of its AV-101
with the National Institute for Mental Health (NIMH), the mental health arm of
the National Institutes of Health (NIH), builing on encouraging signs of safety
and the drug’s potential to better combat major depression without the lag in
onset of therapeutic benefits and some of the serious side effects often
associated with currently-available anti-depression therapies and treatments.
With
nearly $9 million of prior support from the NIH, VistaGen has been working
diligently to develop AV-101 for various diseases and conditions of the central
nervous system (CNS), including depression, chronic pain and other CNS
disorders, and AV-101 is reportedly showing the notable potential for success
in combating one of the most prominent disorders in the world – one which is
estimated to affect about 1 in 20 people globally and indirectly impacts
families and friends of those sufferers. That potential has now caught the
attention of the NIMH, which is expected to collaborate with the company and
sponsor its upcoming Phase 2 clinical study of AV0-101 in major depression.
In its
NIH-funded Phase 1 clinical trials in healthy volunteers, AV-101 was safe, with
no adverse side effects. In those studies, multiple subjects on AV-101 (none on
placebo) expressed positive feelings of well-being similar to ketamine’s
rapid-onset antidepressant effects, without any of ketamine’s serious side
effects. There were no reports of hallucinations, sedation or any
schizophrenia-like effects which have been reported with drugs such as ketamine
and similar treatments that have produced what are called rapid-onset
antidepressant results.
This Phase
2 trial is due to be both started and completed in 2015, offering hope for a
potential safe and effective breakthrough treatment for major depression,
something that has eluded patients and healthcare professionals for decades.
For more
information, visit www.vistagen.com
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