NRx Pharmaceuticals Provides Progress Update on Interactions with the FDA regarding Path to NDA Submission for NRX-101

NRx Pharmaceuticals

RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that it recently had a meeting and a written response from the Food and Drug Administration (FDA) regarding its lead compound, NRX-101.

In response to a request for Type C guidance on the chemistry, manufacturing and controls (CMC) aspects of the NRX-101 program, FDA provided Written Responses on January 10th.  As previously announced in October 2022, an updated NRX-101 module 3 was submitted to add the intended commercial manufacturer to the IND. With FDA’s written response, it appears that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan.

A Type B meeting with the FDA was held on January 11, 2023.

Minutes of the meeting are expected to be available in approximately 30 days.

“We appreciate the FDA’s ongoing guidance and support under the Breakthrough Therapy Designation associated with NRX-101 as well the previously issued Special Protocol Agreement for the treatment of Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior.  Our quest is to develop the first medicine to treat patients with suicidal depression and aim to develop a new drug therapy for post-traumatic stress disorder (PTSD)”, said Stephen Willard, chief executive officer of NRx Pharmaceuticals.  “We look forward to continued discussions addressing our mutual goal to treat bipolar depression and suicidality at a time when someone in the United States attempts suicide every 27 seconds.”

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