According
to a report published in September of 2014 by Transparency Market Research on
anxiety disorder and depression treatments, the global market for depression
treatment was around $22.5 billion in 2013 and is estimated to be running at
around a 1.25% CAGR for the 2014 through 2020 period, after which it will reach
some $18.2 billion. An increase in the availability of generic formulations,
combined with the expiry of patents on such major facets in the market as Eli
Lilly’s (NYSE:LLY) Cymbalta, Pfizer’s (NYSE:PFE) Effexor XR and Actavis’
(NYSE:ACT) Lexapro, is turning increasing attention to a limited number of
newcomers into the market which are on the horizon. Newcomers that are able to
offer compelling advantages over existing SNRI (serotonin-norepinephrine
reuptake inhibitor) and SSRI (selective serotonin reuptake inhibitor)
medications in particular, which have drawn increasing scrutiny in recent years
due to their marginal efficacy and a wide range of potentially serious
complications, like potential life-threatening birth defects in the offspring
of women taking these antidepressants while pregnant, as well as sexual
dysfunction, nausea and insomnia, and risk of suicidal thoughts and behaviors.
Indeed,
only about 30% of depression sufferers respond to first round treatments with
SSRI/SNRI medications and these drugs must be taken for many weeks in most
cases before any noticeable decline in depression is noticed. In the case of
MDD (major depressive disorder), which is characterized as severe, chronic
unhappiness, a condition experienced by some 16 million adults in the U.S.
during 2012 alone (7% of population), an estimated 15% of sufferers ultimately
take their own lives and extant antidepressants have been show to exacerbate
problems in many cases.
This
is one major reason the powerful anaesthesia, sedative and pain reliever,
ketamine, despite its potentially severe side-effects like memory loss,
psychosis and liver damage, has risen to prominence as an MDD treatment
following several exploratory clinical studies at the U.S. National Institutes
of Health (NIH). Another major reason is the distinct pharmacokinetics of
ketamine, which has demonstrated rapid onset antidepressant effects in MDD
patients who showed little or no response to standard antidepressant
medications. The clear drawbacks of ketamine and the obvious risk of abuse, due
to the drug having become a popular street drug because of its hallucinogenic
effects, mean that widespread therapeutic use will likely never occur. However,
ketamine’s pharmacokinetics are quite interesting, because the drug is a potent
NMDA (N-methyl-D-aspartate) receptor antagonist and NMDA channel blocker.
Because the NMDA receptor has been shown to be a key glutamate receptor and ion
channel protein in nerve cells, and because it is now becoming clear how
important the glutamatergic system is to regulating mood and overall
neurobiological states in individuals, substances which can effectively
regulate NMDA receptor activity rather than block it are currently being focused
on for development as broad-spectrum depression treatments.
The
market is ripe for a new generation of real alternatives to SSRIs and SNRIs,
agents that can help treat anxiety, depression and MDD in particular, without
the dangerous side effects and potential for abuse, and that is where VistaGen
Therapeutics (OTCM:VSTA) comes in, with their unique, orally-active prodrug
candidate, AV-101. Because AV-101 is able to efficiently cross the blood-brain
barrier, where it is converted quickly into the extremely well-characterized
and highly potent selective NMDA receptor antagonist 7-Cl-KYNA
(7-chlorokynurenic acid), its fundamentally novel mechanism of action may
deliver all the benefits of ketamine, without the serious side effects.
The
NIH funded $8.8 million of VistaGen’s preclinical and Phase 1 clinical
development of AV-101. In two successful NIH-funded AV-101 Phase 1 safety
studies, there were no signs of ketamine’s sedative, hallucinatory or
schizophrenia-like side effects. VistaGen also recently announced in
mid-February 2015 that they have subsequently entered into a cooperative
research and development agreement with the NIH’s National Institute of Mental
Health (NIMH) division to collaborate on an NIH-funded Phase 2 clinical study
of AV-101 in MDD. VSTA’s AV-101 is now in a prime position to emerge as one of
the leading candidates in the next wave of agents in the global antidepressant
market. With some 350 million people worldwide suffering from depression,
according to the World Health Organization’s analysis (as much as 15% of men
and 25% of women), there is an immense underlying demand that goes well beyond
the critical MDD market being validated for AV-101. A novel mechanism of
action, safety, rapid onset efficacy and oral-availability all may spell gold
for AV-101.
Learn
more by visiting www.VistaGen.com
About MissionIR
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
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
