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Clinical Trials

NeuroRx, Inc. is a clinical stage pharmaceutical company that is developing NRX-101, the first oral therapeutic for the treatment of Acute Suicidal Behavior/Ideation (ASIB) in Bipolar Disorder. The company is built upon 30 years of basic science and clinical expertise in understanding the role of the brain’s N-methyl-D-aspartate (NMDA) receptor in regulating human thought processes in general and in regulating depression and suicidality in specific.

NeuroRx’s investigational treatment approach begins with a single dose of ketamine, an FDA approved anesthetic, followed by approximately six weeks of daily oral NRX-101. NRX-101 is being developed as a rapid-onset and sustained treatment for acute suicidal crisis associated with bipolar depression. NRX-101 combines D-cycloserine, an N-methyl-D-aspartate (NMDA) receptor modulator; and lurasidone, a 5-HT2a receptor antagonist.

Peer-reviewed and published results from two Phase II clinical studies demonstrate a significant decline in symptoms of depression and suicidality following administration of D-cycloserine. Findings from one of these studies found that bipolar patients who were already receiving a 5-HT2a antagonist demonstrated more than a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation when ketamine and D-cycloserine were added to their treatment regimen. Side effects for patients in a P2a combination study of D-cycloserine and 5HT2a included mild sedation, headaches and hypomania

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