NRx Pharmaceuticals, Inc. has announced the submission of the first section of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NRX-100 (ketamine) for the treatment of suicidal depression. This submission marks a significant step toward providing a potential new treatment option for the millions of Americans who experience suicidal ideation each year.
NRX-100 received Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for 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.
Addressing a Critical Unmet Need
Suicidal depression is a major public health crisis. According to the CDC, over 13 million Americans seriously consider suicide each year, and 3.8 million make a plan to do so. Current treatment options are limited, with electroconvulsive therapy (ECT) being the only FDA-approved treatment specifically for suicidal depression.
"New treatment options are urgently needed for people at risk with acute suicidal depression," said Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist of NRx Pharmaceuticals. He noted that while ketamine is already widely used off-label for this condition, its use is largely unreimbursed by health insurers without FDA approval.
NRX-100: A Novel Ketamine Formulation
NRX-100 is an intravenous ketamine formulation that differs from ketamine used in anesthesia. It contains no potentially toxic preservatives and utilizes diversion-resistant packaging to enhance traceability, addressing concerns about abuse potential.
Regulatory Pathway and Market Potential
While the clinical data sections of the NDA are being finalized, the FDA has requested the submission of the 1800-page manufacturing section (Module 3) for immediate review. The complete NDA filing is expected in the first quarter of 2025.
Intravenous ketamine is increasingly accepted as a standard of care for acute treatment of suicidal depression, even in the absence of an FDA-labeled product. NRx Pharmaceuticals estimates a potential market of $3-5 billion at expected pricing, based on the 3.8 million Americans who plan for suicide each year, according to the CDC.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company's NMDA platform is the basis for NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx also plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia.
