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:
Safety Considerations Known To Date of this Regimen:
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