NeuroRx is developing the first Glx targeted antidepressant to address suicidality in bipolar depression. Lead candidate, NRX-101 is in Phase 2b/3 development, initiated in July 2019 (Breakthrough Designation, SPA and Fast Track Designation by FDA) for Severe Bipolar Depression in pts w Acute Suicidal Ideation and Behavior. NRX-101 is a patented, oral, fixed-dose combination of two FDA approved drugs: D-cycloserine, an N- methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, an FDA-approved D2/5-HT2a receptor antagonist. The Company reported Phase 2 efficacy and safety data for NRX-011 in December 2018, suggesting potential for NRX-101 in maintaining remission from several bipolar depression with acute suicidal ideation following an initial stabilization with ketamine. There is no currently approved drug for bipolar depression with suicidal ideation and the only FDA-approved treatment remains ECT.
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