Millions of people around the world suffer from depression, which ranges from short-lived emotional responses to something as severe as suicide, positioning the mental disease as the leading cause of disability worldwide and a dire global health concern.
While recommended depression treatment options range from psychosocial support combined with antidepressant medication or psychotherapy, scientists are seeking new, rapid-acting and more effective treatments than those currently offered in the marketplace.
The World Health Organization (WHO) estimates that globally 350 million people suffer from depression, prompting the organization in 2012 to call for a comprehensive, coordinated response to metal disorders at a country level. The WHO’s Mental Health Gap Action Programme (mhGAP) aims to help countries utilize proper care, psychosocial assistance and medication to increase services for people with mental, neurological and substance abuse disorders.
Here in the states, the U.S. National Institutes of Health (NIH) has conducted clinical trials of ketamine, an FDA-approved anesthetic and adversely used street drug, as a potential antidepressant. While ketamine demonstrates the ability to rapidly alleviate symptoms of depression – compared to current treatments which can take weeks before any therapeutic benefit is achieved – widespread clinical use of ketamine is severely limited due to its high risk for abuse and behavioral impairment, hallucinogenic and schizophrenic-like side effects, and inconvenient intravenous administration in a medical center.
Still, ketamine’s astounding antidepressant benefits have motivated biopharmaceutical companies like VistaGen Therapeutics to aggressively pursue a breakthrough new generation of depression medications.
VistaGen is developing AV-101, a novel, potent and orally- active NMDA receptor (NMDAR) glycine-binding site antagonist. In preclinical studies involving the NIH, AV-101 achieved the fast-acting antidepressant effects of ketamine – but AV-101 greatly differed in that it did not induce the adverse and psychosis-like side effects associated with ketamine and other classic NMDAR channel blockers.
In mid-February 2015, VistaGen broke ground and entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institute of Mental Health (NIMH), part of the NIH. Per the CRADA, VistaGen and the NIMH will collaborate on an NIH-sponsored phase 2 clinical study of AV-101 to evaluate the efficacy and safety of the drug candidate in subjects with major depressive disorder (MDD). The study is expected to begin in the first half of this year.
VistaGen isn’t leaving much room for mistakes. The company recently welcomed key opinion leader Gerard Sanacora PhD, MD, professor of Psychiatry at the Yale School of Medicine and director of the Yale Depression Research Program, to its Clinical and Scientific Advisory Board. Dr. Sanacora will collaborate with VistaGen to focus on phase 2 and phase 3 clinical development of AV-101 in MDD.
In addition to depression, VistaGen is also pursuing applications of AV-101 for other indications involving the central nervous system, including chronic neuropathic pain, epilepsy and neurodegenerative diseases such as Parkinson’s and Huntington’s disease. The WHO’s invigorated push for a new approach to depression treatment, however, along with the NIH’s willingness to fully-sponsor the impending Phase 2 clinical study, validates VistaGen’s primary focus of advancing AV-101’s potential as a revolutionary antidepressant for the millions globally who are inadequately served by current medications.
For more information, visit www.vistagen.com
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