© 2016 NeuroRx, Inc.

*This drug is investigational and not approved by the US FDA

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Overview

 

 

 

NeuroRx’s lead drug candidate NRX-101 (Cyclurad™), if approved by the FDA, would be the first oral therapeutic for the treatment of Acute Suicidal Ideation/Behaviot (ASIB) in Bipolar Depression.  NRX-101 is a proprietary, oral-fixed dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator; and Lurasidone (Latuda®), a 5-HT2a receptor antagonist.

 

NeuroRx’s investigational treatment approach begins with a single infusion of ketamine, an FDA-approved anesthetic, followed by approximately six weeks of daily oral NRX-101.  The company expects to initiate a Phase 2b/3 clinical trial of NRX-101 for the treatment of ASIB in Bipolar Depression in early 2017.

 

NeuroRx believes that NRX-101, if successful, may offer a number of clinical advantages, including:

 

  • Specific Focus on Bipolar Patients:  Competitors’ pipeline products are focused on Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD).

 

  • Convenience: Unlike other treatments in development, NRX-101 (Cyclurad™) is expected to allow treatment on an outpatient basis after an initial stabilization with Ketamine in a clinical setting.

 

  • Not Expected To Be a Controlled Substance: Unlike Ketamine and its derivatives, the two active ingredients of Cyclurad™ are not controlled substances regulated by the Drug Enforcement Agency (DEA).

 

  • Rapid Stabilization for Patients with a single dose of Ketamine: The NRX-101 treatment regimen will only require a single, initial administration of Ketamine which has shown an anti-suicidal benefit. Ketamine can cause dissociative effects (hallucinations); repeated administration could further increase this.

  • Safety Considerations Known To Date of this Regimen:
    • Ketamine can cause dissociative effects (hallucinations); repeated administration could further increase this, vasovagous reactions.
    • Side effects for patients in a P2a combination study of D-cycloserine and 5HT2a included mild sedation, headaches and hypomania

 

 

 

 

 

NRX-101 (Cyclurad) is being developed as the first oral, outpatient therapy for ASIB in Bipolar Depression, after initial stablization w/ ketamine.

This drug is investigational, and not approved by the US FDA