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:
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