{"id":17022,"date":"2014-03-03T17:52:06","date_gmt":"2014-03-03T22:52:06","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=17022"},"modified":"2014-03-03T17:52:06","modified_gmt":"2014-03-03T22:52:06","slug":"fda-fast-tracks-depression-drug-from-northwestern-spin-off","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=17022","title":{"rendered":"FDA Fast-Tracks Depression Drug from Northwestern Spin-Off"},"content":{"rendered":"
\"Neuron<\/a>
(National Institute on Aging, NIH)<\/figcaption><\/figure>\n

Naurex Inc.<\/a>, a biotechnology company in Evanston, Illinois, says the U.S. Food and Drug Administration granted fast-track status for its drug candidate code-named GLYX-13 to treat depression. GLYX-13<\/a> is Naurex’s lead product for treatment of central nervous system disorders.<\/p>\n

The company develops drugs for diseases of the central nervous system that stimulate N-Methyl-D-aspartate (NMDA) receptors, molecules found in synapses, a part of nerve cells that permit sending and receiving of signals. NMDA receptors<\/a> help keep synapses flexible, which affects memory, learning, and development of the central nervous system. Naurex aims to use this platform<\/a> to develop drugs to treat mood and anxiety disorders, cognitive disorders, neurodegenerative diseases, developmental disorders, neuropathic pain, and addiction.<\/p>\n

GLYX-13 is in intermediate-stage clinical trials being tested as a back-up drug for patients with major depressive disorder not responding to earlier antidepressants. In one trial<\/a>, a single dose of GLYX-13 is being tested against a placebo with 300 patients who did not respond to earlier antidepressants. The company says initial findings show the drug acted quickly, within 24 hours, to reduce depression scores on a standard rating scale, compared to patients receiving the placebo, with results lasting several days.<\/p>\n

FDA’s fast-track designation<\/a>, as the name implies, offers accelerated review to drugs with the potential to addres serious conditions or unmet medical needs. With fast-track status, FDA schedules more frequent meetings and provides more frequent correspondence. Fast-track status also provides for partial submissions and rolling review of a company’s new-drug or biological license applications, rather than waiting for the entire applications to be completed before submission.<\/p>\n

Naurex is a spin-off company from Northwestern University, founded by biomedical engineering professor Joseph Moskal<\/a>, who continues as the company’s chief scientist. Moskal is also director of the Northwestern’s Falk Center for Molecular Therapeutics<\/a> that calls itself a “new organizational model … to translate discoveries with therapeutic potential into clinically useful compounds.” Part of that new model, says the Falk Center, is Naurex Inc., to which the center says is “tethered.”<\/p>\n

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