NRx Pharmaceuticals announces first section of NDA for NRX-100

NRx Pharmaceuticals (NRXP) announced the transmission of first section of its New Drug Application, NDA, for NRX-100 for electronic filing with the U.S. Food & Drug Administration, FDA. NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 for treatment of suicidal bipolar depression. The Company is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression. “New treatment options are urgently needed for people at risk with acute suicidal depression,” said Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist. “Ketamine is already widely-used for the treatment of suicidal depression on an off-label basis and is funded by the Department of Defense and the Department of Veterans Affairs. However, without FDA approval, its use is largely unreimbursed by health insurers, with the exception of VA and DOD.”