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 treatment regimen is NRX-100/NRX-101, the first sequential drug treatment regimen for Bipolar Depression in patients with Acute Suicidal Ideation & Behavior (ASIB). We have also started to investigate our treatments for PTSD in patients with ASIB
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-100/NRX-101 Breakthrough Therapy Development Program
There are more than 100 suicides each day in the United States, yet, there is no approved therapeutic for the treatment of bipolar depression in patients with acute suicidal ideation and behavior (ASIB). Many commonly used antidepressants are known to have the potential to trigger suicide in certain populations.
NRX-100 & NRX-101 are being developed for Bipolar Depression in patients with Acute Suicidal Ideation & Behavior. NRX-101 is an oral, outpatient therapy intended to extend the rapid, antidepressant and anti-suicidal effect observed in clinical studies of NRX-100 (ketamine). Ketamine is an FDA-approved anesthetic. It is not currently approved for this indication.
NRX-101 has been awarded Fast Track Designation and Breakthrough Therapy Designation by the US Food and Drug Administration. 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 NRX-100 (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.1
A second phase 2 study, compared NRX-101 to lurasidone alone following a single infusion of ketamine in patients who presented to emergency care with Severe Bipolar Depression and Acute Suicidal Ideation. Immediate stabilization was achieved with a single infusion of IV ketamine. Patients were then randomized to NRX-101 or to lurasidone and treated for 42 days. Those treated with NRX-101 were seen to have a significantly lower level of depression – 11 points on the Montgomery Asberg Depression Rating Scale (MADRS) at 14 days (P<0.03), a trend which persisted to 42 days (P=0.059).2 On the basis of these findings, the US FDA awarded Breakthrough Therapy Designation to NRX-101.
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 initially being developed to be a physician-prescribed, oral medicine that could be taken on an outpatient basis after initial stabilization with NRX-100 (ketamine).
NeuroRx has initiated pivotal P2b/3 clinical studies under an FDA Special Protocol Agreement (SPA).
These drugs are investigational,
and not approved by the US FDA for this indication
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NRX-100 & NRX-101