FDA Approval; Major Milestone for Preservative-Free Ketamine Ahead of FDA Goal Date for Treatment of Suicidal Depression by NRx Pharmaceuticals, Inc
The Floridant/10352588

MIAMI - Floridant -- NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) $NRXP, a commercial biopharmaceutical company developing medicines that target depression, PTSD, and suicidality has announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine. The approval comes ahead of the FDA-announced November 10, approval Goal Date.

"We are excited to bring Preservative-Free Ketamine to market and give patients and their physicians an option for repeat treatments without the potential dangers of a preservative that has been classified as unacceptable for inclusion in some formulations by the US Food and Drug Administration," said Jonathan Javitt, MD, MPH, NRXP Chairman and Chief Executive Officer.

Currently available ketamine injection products all contain benzethonium chloride (BZT). According to current regulation, inactive ingredients in drugs (including preservatives) must be Generally Recognized As Safe ("GRAS") or proven to be safe. The FDA has declined to designate Benzethonium Chloride as GRAS. Under current FDA policy, benzethonium chloride cannot be included in new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs nor in intravenous formulations above a threshold concentration for toxicological reasons. Ketamine is one of the few remaining old drugs, initially formulated in 1970 to contain BZT. Prior to the NRXP novel formulation, it was widely believed that BZT was required for long-term stability and sterility of ketamine.

NRXP has filed a Citizen Petition with FDA seeking to have BZT removed from ketamine and an expert Toxicology report is available to the public on the FDA docket. That report, compiled by a Board Certified Toxicologist under the supervision of a leading Regulatory Law Firm, documents that at dosages of ketamine that are routinely used in hospitals and clinics for labeled indications, patients may be exposed to levels of BZT that exceed the published toxicity thresholds.

Federal policymakers have addressed the threat to the United States of a sterile injectable drug supply that is largely manufactured offshore. Traditional, labor-intensive, glass bottle manufacturing of these drugs has not been economically viable in the United States for decades. The NRXP presentation of Ketamine demonstrates that manufacture of old-line sterile, injectable drugs can be reshored to the United States for the benefit of American patients, workers, and investors.

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The approval of Ketamine ahead of its Generic Drug User Fee Act (GDUFA) goal date by the FDA Office of Generic Drugs demonstrates FDA's commitment to timely and efficient approval of drug-shortage drugs.

Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine

NRXP has announced completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Act) Goal Date. Process Validation is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP).

NRXP has also completed analysis of two-year room temperature real-time stability data on preservative-free ketamine demonstrating no deterioration in purity, potency, or sterility without the need for toxic preservatives. NRXP believes that these data will be consistent with a labeled shelf life of three years or longer.

$11 Million Dollar DARPA Prime Contract Award to Evaluate Robotic Magnetic Stimulation in Conjunction with NRX-101 for Treatment of Resistant Depression

NRXP subsidiary NRx Defense Systems has announced the award of an initial $11,177,757.27 contract issued by the Defense Advanced Research Projects Agency, a Branch of the United States Department of War. The underlying clinical trial, the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) trial has been approved by the US Food and Drug Administration and will now begin enrolling patients.

The NRXP SPARC-TMS trial will be conducted at Harvard Medical School's McLean Hospital, Arizona State University, and HOPE Therapeutics. Several leading military hospitals will also be affiliated with the study.

The focus of SPARC-TMS is to test whether an entire course of TMS delivered in a single day can effectively treat major depressive disorder when combined with mechanism-guided pharmacologic augmentation with NRXP NRX-101. TMS is thought to exert its therapeutic effects primarily through synaptic plasticity – the cellular basis of learning and memory. Synaptic plasticity is mediated by NMDA receptors. NRX-101 combines two drugs that may enhance NMDA receptor function through complementary mechanisms: d-cycloserine, an NMDA receptor partial agonist, and lurasidone, which has been shown to increase NMDA receptor expression through 5-HT7 antagonism.

The SPARC-TMS trial has the potential to serve as an FDA registration study for the use of NRXP NRX-101 in conjunction with TMS for people with Treatment Resistant Depression. a far larger population of patients, estimated at 8.9 million American adults with an estimated $44 Billion burden of illness.

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European Patent Rights for GNK-301, a Novel Drug Candidate to Treat Amyotrophic Lateral Sclerosis (ALS)

GeNeuro, Inc., a subsidiary of NRXP has announced the award of a European Patent (EP 3 570 878 B1) entitled "Anti HERV K Envelope Antibody and Uses Thereof." The patent, together with two previously-issued US patents (10,723,787 and 10,981,977) describes in detail the discovery that the envelope protein (K Env) of Human Endogenous Retrovirus K (HERV K) is found in the spinal fluid of more than 75% of people with Amyotrophic Lateral Sclerosis (ALS), is shown to be highly neurotoxic, and to produce the neurodegenerative findings of ALS.

HERVs are the remnants of viruses that infected primates between 2 and 5 million years ago and are now thought to have played a role in human disease. A monoclonal antibody against K Env (GNK-301) has been shown to block those neurotoxic effects in the same models. The patents are jointly owned by GeNeuro and the US Dept. of Health and Human Services.

The assets of the former Geneuro SA were awarded to NRXP GeNeuro, Inc. by the Courts of Switzerland in June 2026 and GeNeuro initiated manufacture of GNK-301 under Good Manufacturing Practices (cGMP) with the plan to initiate human Phase 1 trials of GNK-301 in the US and Europe in the latter half of 2027.

FDA Approval of Preservative-Free Ketamine Received Ahead of November 10th FDA Goal Date.

Ketamine, Originally Formulated in 1970 is One of the Last Remaining Sterile Drugs to Contain the Preservative Benzethonium Chloride.

Plan to Return sterile, Injectable Drug Manufacture to the US and end the Current Shortage of Traditional Glass-Bottled Ketamine via Modern, High-Volume Means.

Approval Demonstrates Sterile, Injectable Drug Manufacturing can be Reshored to the US from Overseas Sources of Supply Using Modern Technology.

Three Commercial Lots of Preservative-Free Ketamine Manufactured in Compliance with "Process Validation" Required Under FDA "Good Manufacturing Practices" (GMP).

Two Year Stability Data Consistent with Projected Room-Temperature Stability to Three Years and Beyond with No Need for Toxic Preservatives.

$11 Million Dollar DARPA Prime Contract Award to Evaluate Robotic Magnetic Stimulation with NRX-101 Drug for Treatment of Resistant Depression,

Plans Underway to Expand SPARC-TMS Trial to Leading Military Hospitals.

Subsidiary GeNeuro, Inc., Awarded European Patent Rights for GNK-301, a Novel Drug Candidate to Treat Amyotrophic Lateral Sclerosis (ALS).

Worldwide Generic Ketamine Market Estimated at $750 Million Per Year.

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For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

Media Contact
Company Name: NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Contact Person: Brian Korb, Managing Partner, astr partners
Email: brian.korb@astrpartners.com
Phone: (917) 653-5122
Country: United States

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