NeuroRx has FDA clearance to commence Phase II/III trial of NRX 101 to treat acute suicidal ideation and behavior in Bipolar Depression (ASIB) and depression.

NeuroRx has received FDA clearance to proceed with its phase IIb/III study protocol under an Investigational New Drug (IND) application and is now enrolling study sites for its clinical trial of NRX-101.

The clinical trial seeks to demonstrate that NRX-101 is safe and effective in maintaining remission from Acute Suicidal Ideation and Behavior in Bipolar Depression (ASIB) and depression following initial stabilization with ketamine. The Mass General Clinical Trials Network and Institute will provide leadership for the clinical trial, and Prof. Andrew Nierenberg, M.D., Director of Bipolar Research in the department of Psychiatry at Massachusetts General Hospital will serve as the study's Principal Investigator.

Comment: More than 3 million Americans have bipolar depression , sometimes known as manic depression, a subset of whom have active suicidality. Those with bipolar depression are more than twice as likely to commit suicide compared with patients who have other forms of depression.