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NRx Pharmaceuticals Receives FDA Approval to Advance Investigational New Drug (IND) Application for NRX-101 in the Treatment of Chronic Pain

Tuesday, October 03, 2023

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced today that it has received FDA clearance to proceed with human trials for the treatment of chronic pain under its Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for NRX-101. This IND application is based on pioneering research into the use of D-cycloserine, a key component of NRX-101, for chronic pain treatment, as well as NRx's recent acquisition of a U.S. patent for D-cycloserine's application in pain management.

Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, Inc., commented on the development, saying, "Over one in five adults in the United States suffer from chronic pain, and there is a need for treatment options that do not carry the risks associated with addiction and opioid side effects. We are pleased that our IND received clearance for clinical trials within just 30 days of filing, and we are eager to advance the development of NRX-101 for chronic pain." He also noted the intention to pursue Fast Track Designation, Priority Review, and Breakthrough Therapy Designation due to promising preliminary evidence of D-cycloserine's efficacy in chronic pain management.

Dr. Javitt further added, "Having already completed essential manufacturing activities to support our program in suicidal depression, we have an adequate supply of our investigational drug ready for registrational studies for chronic pain in 2024, pending the results of the recently concluded clinical trial funded by the U.S. Department of Defense.

Chronic pain represents a substantial market, estimated at $72 billion today, with projections of reaching $120 billion by 2033.

In June 2023, NRx Pharmaceuticals made a significant announcement in tandem with its Alvogen partnership. The company expanded its NRX-101 program to include the treatment of chronic pain as a focal point for further development.

Additionally, NRx Pharmaceuticals secured the licensing of US Patent 8,653,120, which pertains to the use of D-cycloserine (DCS) in chronic pain treatment. Furthermore, Dr. Apkar Vania Apkarian, a distinguished expert in pain research and the inventor of the patent, joined NRx's Scientific Advisory Board, contributing valuable insights from his experience in studying DCS for chronic pain management.

DCS has demonstrated its ability to modulate the Pain Pathway at various points along the neural chain of pain, including spinal cord dorsal horn transmission, pain perception in the thalamus (referred to as the "paleo brain"), and pain memory and processing between the paleo brain and the cortex.

Both experimental models and clinical studies have indicated that NMDA antagonists, such as DCS, can alleviate pain and potentially reduce cravings for opioids. Importantly, DCS does not carry the risk of addiction associated with ketamine and other NMDA antagonists that bind to the "mu" opioid receptor.

DCS underwent a pilot study at Northwestern University, demonstrating efficacy, particularly at higher dose levels, as evidenced by Schnitzer in 2016. Currently, a confirmatory trial funded by the US Department of Defense under the Congressionally Directed Medical Research Program is in progress. This trial aims to enroll approximately 200 participants with chronic low back pain at Northwestern University ( NCT03535688), with data collection completed and statistical results expected soon.

NRx Pharmaceuticals conducted research revealing that a 25 μg/ml dose of D-cycloserine functions as an NMDA antagonist. Notably, the 400mg dose employed in the Northwestern University confirmatory trial falls at the lower end of this threshold, suggesting the potential to increase the DCS dose beyond 400mg, with the use of lurasidone to mitigate central nervous system (CNS) side effects in NRX-101.

NRX-101 is a noteworthy pharmaceutical innovation featuring a distinct composition and several promising designations from the FDA. It comprises a fixed-dose combination of D-cycloserine and lurasidone and has garnered significant recognition from the FDA, including ,Fast Track Designation,Breakthrough Therapy Designation,Special Protocol Agreement,Biomarker Letter of Support

These designations have been granted in recognition of NRX-101's potential application in treating Suicidal Treatment Resistant Bipolar Depression (S-TRBD). Furthermore, NRX-101 is under investigation for its potential utility in managing chronic pain and addressing PTSD.

Suicidal Treatment Resistant Bipolar Depression (S-TRBD) represents a complex and high-risk condition, with a substantial suicide risk. It's estimated that up to 50% of individuals with bipolar disorder make suicide attempts at some point, and as many as 20% may tragically die by suicide. Currently, electroconvulsive therapy stands as the sole FDA-approved treatment for patients grappling with treatment-resistant suicidal bipolar depression.

Conventional antidepressants, on the other hand, can elevate the risk of suicide in specific patient populations, leading to warning labels on their use. NRX-101 distinguishes itself as a patented oral medication, combining D-cycloserine and lurasidone, both of which have not exhibited addiction potential in preclinical models.

The FDA granted Breakthrough Therapy Designation to NRX-101 based on compelling results from a Phase 2 proof-of-concept study. This designation specifically pertains to the treatment of severe bipolar depression in patients with Acute Suicidal Ideation and Behavior (ASIB), following initial stabilization with ketamine or other effective treatments.

Significantly, NRX-101 is among the pioneering oral antidepressants currently undergoing late-stage clinical studies, focusing on targeting the NMDA receptor in the brain. This innovative approach holds promise for treating depression, including cases involving suicidality. Additionally, it is being explored for its potential in addressing chronic pain, PTSD, and other medical conditions. NRX-101's potential utility in managing Urinary Tract Infections (UTI) is also under consideration.

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