NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced its expanded access policy for NRX-100 (preservative-free ketamine) after receiving FDA Fast Track designation for the treatment of suicidal ideation in patients with depression, including bipolar depression. The designation reflects FDA’s determination that NRX-100 may address an unmet need based on preliminary data. Eligible patients may access the investigational therapy under specific conditions, including lack of response or tolerance to approved treatments and sufficient supporting clinical data. Chairman and CEO Dr. Jonathan C. Javitt said the company is committed to making NRX-100 available to patients with suicidal depression who have limited options, while continuing to advance its clinical development program.
To view the full press release, visit https://ibn.fm/vwPG1
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia.
NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression. The filing is based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France, licensed under a data sharing agreement.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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