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FDA Fast-Tracks Depression Drug from Northwestern Spin-Off

Neuron illustration (NIH)

(National Institute on Aging, NIH)

Naurex Inc., 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 is Naurex’s lead product for treatment of central nervous system disorders.

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 help keep synapses flexible, which affects memory, learning, and development of the central nervous system. Naurex aims to use this platform to develop drugs to treat mood and anxiety disorders, cognitive disorders, neurodegenerative diseases, developmental disorders, neuropathic pain, and addiction.

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 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.

FDA’s fast-track designation, 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.

Naurex is a spin-off company from Northwestern University, founded by biomedical engineering professor Joseph Moskal, who continues as the company’s chief scientist. Moskal is also director of the Northwestern’s Falk Center for Molecular Therapeutics 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.”

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