NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine)

Core Viewpoint - NRx Pharmaceuticals has announced an expanded access policy for NRX-100, a preservative-free ketamine, following its Fast Track designation by the FDA for treating suicidal ideation in patients with depression, including bipolar depression [1][6]. Group 1: Expanded Access Policy - NRX-100 is now available for expanded access to eligible patients, addressing an unmet need in treating suicidal depression [2][6]. - Physicians can request NRX-100 for patients who are not responsive to or cannot tolerate approved treatment options [3][7]. - The company emphasizes the urgent need for NRX-100 for patients with suicidal depression [3]. Group 2: FDA Designation and Clinical Development - The FDA granted Fast Track designation for NRX-100 based on preliminary data indicating its potential to meet an unmet medical need [2][6]. - NRX Pharmaceuticals is also developing NRX-101, which has received Breakthrough Therapy Designation for treating suicidal bipolar depression [5]. Group 3: Patient Statistics and Clinical Trials - Approximately 13 million adults in the U.S. seriously consider suicide each year, with a suicide occurring every 11 minutes [6]. - NRX has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application for NRX-100, based on results from well-controlled clinical trials [8].