NRx Pharmaceuticals Announces Major Progress in Path to NDA Submission for Promising New Treatment: NRX-101

Last week, NRx Pharmaceuticals, Inc., a clinical-stage central nervous system (CNS) biopharmaceutical company, had a productive meeting with the Food and Drug Administration (FDA), who then provided a written response regarding their lead compound, NRX-101. This marks a significant milestone in NRx’s mission to provide innovative treatments for CNS disorders.

After much anticipation, NRx Pharmaceuticals has finally reached alignment with the FDA in regards to their proposed registration manufacturing plan for the NRX-101 program. On January 10th, the FDA provided Written Responses to the CMC aspects of the program, which followed the submission of an updated NRX-101 module 3 in October of 2022, adding the intended commercial manufacturer to the IND. This is an exciting milestone in the progress of the NRX-101 program.

On January 11, 2023, a Type B meeting with the FDA was held to discuss important topics and further progress in the industry. It was a remarkable occasion, as it provided an opportunity to collaborate and exchange ideas with renowned professionals in the field. The meeting was a great success, setting the stage for future endeavors.

The minutes of the meeting will be available in around a month’s time. Keep an eye out for them to stay up to date with the latest developments!

At NRx Pharmaceuticals, our mission is to develop the first ever medicine for patients suffering from suicidal depression and post-traumatic stress disorder (PTSD). We are deeply grateful to the FDA for their support and guidance through the Breakthrough Therapy Designation and Special Protocol Agreement associated with our NRX-101 treatment for Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior. As the alarming statistic of a suicide attempt every 27 seconds in the United States stands testament to, we are determined to take steps towards achieving our goal and make a real difference in the lives of those affected.

About NRx Pharmaceuticals

NRX Pharmaceuticals is a clinical-stage biopharmaceutical company that is on the cutting-edge of developing therapeutics for the treatment of central nervous system disorders, with a focus on suicidal depression and post-traumatic stress disorder (PTSD). Their lead program NRX-101, an innovative oral, fixed-dose combination of D-cycloserine and lurasidone, is designed to target the brain’s NMDA receptor. Currently, the program is undergoing a Phase 3 trial under the FDA’s Special Protocol Agreement and Breakthrough Therapy Designation, aiming to provide an alternative to electroshock therapy in patients with bipolar depression and suicidal ideation. Furthermore, the company has initiated a Phase 2b clinical trial in patients with Sub-Acute Suicidality, which represents a substantially broader indication. This progress has been largely driven by the success of the STABIL-B trial, which showed substantial improvement over existing therapies in reducing depression and suicidality when treated with NRX-101 after a single dose of ketamine.

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