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NeuroRx is developing NRX-101, an FDA-designated Breakthrough Therapy targeting Suicidal Bipolar Depression. NRX-101 is a fixed dose combination of D-cycloserine and lurasidone, which is believed to raise Glx in the brain, as does ketamine and ECT.
NeuroRx draws upon 30 years of basic science and clinical expertise in the role of N-methyl-D-aspartate (NMDA), a receptor that regulates human thought processes, particularly depression and suicidality, as well as PTSD. The company is privately funded and led by former senior executives of Johnson & Johnson, BMS, Pfizer Inc., Eli Lilly, and Sunovion.
NeuroRx has entered an FDA phase 2b/3 pivotal trial under a Special Protocol Agreement and a Biomarker Letter of Support for treatment of patients with Severe Bipolar Depression and Acute Suicidal Ideation. Phase 2 data demonstrated an 11 point advantage on MADRS depression scale at day 14 vs. lurasidone alone (P=0.03) and a sustained separation through day 42 (P=0.059).