If
you think depression only affects the individual suffering from the disorder,
or even their friends and family, think again. As a nation, depression affects
all of us in one way or another. According to a report from the Journal of
Clinical Psychology, a staggering amount of that impact is economic.
Depression
(MDD) is the leading cause of disability for people aged 15-44, reports
OptumHealth Reporting and Insights. Financially, that equates to billions of
dollars spent on workplace costs, direct costs (which includes medical claims
and pharmaceuticals) and suicide-related costs. Annual costs of MDD rose 21% to
$210.5 billion in 2010, according to the Journal of Clinical Psychology,
compared to costs in 2005.
Most
experts agree that depression rates worldwide are on the rise. While there are
nearly 50 variations of anti-depressants available in the U.S. alone, the often
extensive trial and error process of finding a drug combination that reduces a
patient’s depression symptoms is known to take months, even more than a year,
and involves risks of serious side effects, including suicide. Studies show
that fewer than 40% of depression sufferers benefit from first round treatments
with current antidepressants, and the likelihood of achieving remission of depressive
symptoms declines with each successive treatment attempt. Even more atrocious,
as many as 15% of individuals suffering with MDD commit suicide.
There
is an obvious, unarguable need for a breakthrough – a new generation of safe
and faster-acting antidepressants.
One
such candidate is ketamine, often used as an anesthetic but also popular as a
dangerous street drug. The risk of potential abuse of ketamine, its intravenous
administration, and its psychosis-like side effects somewhat crimp widespread acceptance
in the medical field. And yet, ketamine’s rapid-acting effectiveness against
treatment-resistant MDD is hard to ignore.
In
San Francisco, a publicly traded, clinical-stage biopharmaceutical company is
hard at work advancing its equally, if not more promising, solution – AV-101,
an orally active NMDA receptor modulator.
Backed
with funding by the U.S. National Institutes Health (NIH), VistaGen
Therapeutics is collaborating with Dr. Carlos Zarate – a highly esteemed NIH
clinician known for his deep experience with ketamine and other NMDA receptor
antagonists – on a phase 2 clinical study of the efficacy and safety of AV-101
in subjects with MDD. As reflected by the NIH’s support, VistaGen’s AV-101 has
the potential to deliver the rapid-acting antidepressant effects of ketamine,
but without any of ketamine’s serious side effects.
Dr.
Carlos Zarate is among the NIH’s leading clinical researchers on depression and
other mood disorders, serving as the Chief of the Section on the Neurobiology
and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and
Pathophysiology Branch at the National Institutes of Mental Health (NIMH). He
will be the principal investigator of the NIH-funded Phase 2 study of AV-101 in
MDD. VistaGen and the NIH anticipate completing this important study in 2015.
In
two prior NIH-funded randomized, double-blind, placebo-controlled phase 1
safety studies, AV-101 was well-tolerated and not associated with any severe
adverse events. Nor were there any signs of sedation, hallucinations or
schizophrenia-like side effects often associated with ketamine.
In
addition to its candidacy as an effective MDD treatment, preclinical studies
have also shown AV-101 as a potential as a treatment for other widespread
CNS-related conditions, including chronic neuropathic pain and epilepsy,
Parkinson’s and Huntington’s disease.
For
more information, visit www.vistagen.com
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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
