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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