NeuroRx, Inc announced that it has initiated a pivotal Phase 2b/3 study for NRX-101 for the treatment of patients with Severe Bipolar Depression and Acute Suicidal Ideation and Behavior (ASIB). 
 
NRX-101 has been granted Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA. The drug is designed to address bipolar depression with suicidal ideation, an indication for which there is no currently approved drug and for which the only FDA-approved treatment remains electroconvulsive therapy (ECT).
 
“We are delighted to initiate this study of patients suffering from Severe Bipolar Depression and ASIB at JPS Health Network (JPS) in Fort Worth, Texas.  NeuroRx is addressing a life-threatening condition that kills 25,000 Americans each year and for which the only currently approved therapy is ECT, with its known complications.  This study is the first to test a potentially life-saving alternative for patients with an unmet medical need.