© 2016 NeuroRx, Inc.

*These drugs are investigational and not approved by the US FDA

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Overview

 

 

 

 

NeuroRx’s investigational drug regimen NRX-100/NRX-101, if approved by the FDA, would be the first sequential drug regimen to include an oral therapeutic for the treatment of Bipolar Depression in patients with Acute Suicidal Ideation & Behavior (ASIB).  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. NRX-100 is ketamine; an anesthetic approved for surgical procedures, not approved for psychiatric indications.

 

NeuroRx’s investigational treatment approach begins with a single infusion of NRX-100 (ketamine), followed by approximately six weeks of daily oral NRX-101.  The company is initiating a Phase 2b/3 clinical trial of NRX-100/NRX-101 for the treatment of Bipolar Depression in patients with ASIB in late 2017.

 

NeuroRx believes that NRX-100/NRX-101, if successful, may offer a number of clinical advantages, including:

 

  • Specific Focus on Bipolar Depression in Patients with ASIB: Over 50% of individuals with Bipolar Disorder attempt suicide over their lifetime.1 Competitors’ pipeline products are focused on Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD).

  • Rapid Stabilization for Patients after a single dose of NRX-100 (ketamine): The sequential drug treatment regimen* will only require a single, initial administration of NRX-100 (ketamine). In clinical studies, ketamine has already shown rapid-onset, antidepressant/anti-suicidal effects.2 Ketamine can cause dissociative effects (hallucinations); repeated administration could further increase this.

 

  • Convenience: Unlike other treatments in development, NRX-101 is expected to allow treatment on an outpatient basis after an initial stabilization with NRX-100 (ketamine) in a clinical setting.

 

  • NRX-101 Not Expected To Be a Controlled Substance: Unlike ketamine and its derivatives, the two active ingredients of NRX-101 are not controlled substances regulated by the Drug Enforcement Administration (DEA).

 

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.

 

  1. Pallaskorpi, et al. Bipolar Disorders 2017; 19: 13-22
  2. Zarate, C. et al. Biological Psychiatry 2012; 71(11); 939-946

 

 

 

 

NRX-100/NRX-101 is being developed as the first sequential drug regimen for Bipolar Depression in patients with Acute Suicidal Ideation & Behavior (ASIB)

These drugs are investigational,
and not approved by the US FDA for this indication