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VSTA AV-101 Seen as Safe Ketamine Alternative for Major Depressive Disorder
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
