NeuroRx, Inc. is a clinical stage, small molecule pharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders. 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. The company’s lead drug candidate is NRX-101 (Cyclurad™), the first oral therapeutic for the treatment of Acute Suicidal Ideation/Behavior (ASIB) in Bipolar Depression.
NeuroRx is built upon
30 years of basic science and clinical expertise in understanding the role
of the NMDA receptor in regulating human thought processes, depression and suicidality.
NeuroRx's NRX-101 Development Program
There are more than 100 suicides each day in the United States, yet, there is no approved therapeutic for the treatment of acute suicidal ideation and behavior. Many commonly-used antidepressants are known to have the potential to trigger suicide in certain populations.
NRX-101 (Cyclurad™) is being developed for Acute Suicidal Ideation/Behavior (ASIB) associated with Bipolar Depression. It is being developed as an oral, outpatient therapy to extend the rapid, anti-suicidal effect observed in clinical studies of ketamine. Ketamine is an FDA-approved anesthetic. It is not approved for this indication.
NRX-101 combines D-cycloserine, an NMDA receptor modulator; and lurasidone, a 5-HT2a receptor antagonist. NeuroRx’s investigational treatment approach begins with a single infusion of ketamine followed by approximately six weeks of daily oral administration of NRX-101.
Peer-reviewed and published results from two Phase II clinical studies show a significant decline in symptoms of depression 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 given a single infusion of ketamine, followed by the addition of daily, oral D-cycloserine for 8 weeks to their existing regimen. Treatments were well tolerated, with mild sedation being reported by 3/8 subjects, headaches in 2/8 subjects, hypomania in 1/8, and discontinuation due to relapse in 1/8.1
The current standard of care, as published by the American Psychiatric Association consists of voluntary or forced admission to a psychiatric hospital and electroconvulsive therapy (ECT). Although ECT is associated with a decrease in suicide deaths, it requires 6 – 10 sessions of general anesthesia and is known to cause memory loss and confusion.
NRX-101 is being developed to be a physician-prescribed, oral medicine that could be taken on an outpatient basis. NeuroRx expects to begin Phase 2b/3 clinical trials of NRX-101 for the treatment of Acute Suicidal Ideation/Behavior (ASIB) in Bipolar Depression in early 2017.
This drug is investigational, and not approved by the US FDA
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