NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced the transmission of the first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the US Food & Drug Administration (FDA). 

NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for the 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, based on data from NIH- and European Government-funded trials that have been summarized on the Company's website.

While assembly of the clinical data sections is being completed, the FDA has asked the Company to submit the 1800-page manufacturing section (Module 3) of the NDA to enable immediate review before submission of final efficacy data and other sections of the NDA expected in the first quarter of 2025.

The NRx presentation of ketamine differs from the form of ketamine used in anesthesia in that it contains no potentially toxic preservatives. It utilises diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential.

"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," Dr. Javitt added. 

Suicidal depression is considered a national crisis.  According to the CDC over 13 million Americans seriously consider suicide each year and 3.8 million make a plan to do so.