FDA Grants Fast Track Designation to NRx Pharmaceuticals' NRX-100 for Suicidal Ideation in Depression

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100, a treatment developed by NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), for suicidal ideation in patients with depression, including bipolar depression. This designation represents a substantial expansion from its previous 2017 approval for use with NRX-101 in suicidal bipolar depression, now covering a broader patient population. The FDA's decision is based on preliminary data indicating NRX-100's potential to significantly reduce suicidal ideation, with studies showing a 55% response rate in one trial and a 63% remission rate in another, compared to active comparators and placebo, respectively.

The Fast Track designation by the FDA not only accelerates the development and review process for NRX-100 but also supports its eligibility for the Commissioner’s National Priority Voucher Program and the Accelerated Approval Program. These programs are designed to expedite access to treatments for serious conditions with unmet medical needs. NRx Pharmaceuticals plans to post an expanded access policy shortly and will meet with FDA leadership to finalize data for submission under these accelerated pathways.

NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone combination, are part of NRx Pharmaceuticals' NMDA platform aimed at treating central nervous system disorders. The company has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application for NRX-100, leveraging results from well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and the Government of France. For more information on NRx Pharmaceuticals and its developments, visit https://ibn.fm/NRXP.

This advancement in treatment options for suicidal ideation in depression is a critical step forward in addressing a significant unmet need in mental health care. The Fast Track designation underscores the potential of NRX-100 to make a meaningful difference in the lives of patients suffering from this debilitating condition.