NRx Pharma Receives FDA Fast Track Designation for NRX-100 for Treating Suicidal Ideation in Depression

NRx Pharmaceuticals has received FDA Fast Track designation for NRX-100 to treat suicidal ideation in patients with depression, including bipolar depression. The FDA determined that NRX-100 has the potential to address an unmet medical need, aligning with eligibility requirements for the Commissioner's National Priority Voucher Program and FDA's Accelerated Approval Program. The company plans to post an expanded access policy for NRX-100 and seek a meeting with FDA leadership to finalize data for an Accelerated Approval/CNPV application.

NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) has received a significant regulatory milestone as the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. This designation represents a significant expansion of the addressable population for NRX-100, aligning with the company's mission to address the national crisis of suicide.

The Fast Track designation is a critical step in NRx's efforts to bring NRX-100 to market, as it enables the company to work more closely with the FDA and potentially accelerate the approval process. The designation includes an FDA determination that NRX-100 has the potential to address an unmet medical need, aligning with the eligibility requirements for the Commissioner's National Priority Voucher (CNPV) program and the FDA's Accelerated Approval Program [1].

NRx plans to post an expanded access policy for NRX-100 in the coming weeks and seek a meeting with FDA leadership to finalize the data for an Accelerated Approval/CNPV application. The company will also benefit from enhanced communication with the FDA, as well as potential Priority Review and Rolling Review, under the terms of the Fast Track program [1].

NRX-100, a preservative-free intravenous ketamine, has shown promising results in clinical trials. A Columbia University study licensed by NRx demonstrated a 55% response rate (i.e., a 50% reduction in suicidality) compared to a 30% response to an active comparator (P.02) [1]. Additionally, a trial sponsored by the Government of France and licensed by NRx showed that 63% of patients achieved full remission from suicidal ideation in three days compared to 31% of those who received placebo (P.001) [1].

The market for suicidal depression is substantial, with approximately 13 million adults seriously considering suicide each year and an American dying from suicide every 11 minutes [1]. NRX-100, if approved, has the potential to address this critical public health issue and make a potentially life-saving therapy available to all Americans, not just those who can afford to pay out of pocket.

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) [1].

References:

[1] https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-granted-fda-fast-track-designation-for-nrx-100-for-suicidal-ideation-in-patients-with-depression-including-bipolar-depression-302526237.html