Commercial Sales for U.S.-Made, Preservative-Free Ketamine Amid Long-Runnin Shortage Following FDA Approval by NRx Pharmaceuticals, Inc

MIAMI - PrZen -- 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 it commenced selling its newly approved preservative-free ketamine providing a guaranteed, U.S.-manufactured supply of a drug listed as in shortage since 2018.

All ketamine injection products currently available in the U.S., having been in short supply since 2018, contain the preservative benzethonium chloride (BZT), which FDA has not determined to be generally recognized as safe and effective (GRASE) for OTC antiseptic hand rubs. NRXP injectable ketamine is preservative-free and comes in a needle-free blow-fill-seal (BFS) vial with a luer-lock tip that attaches directly to a sterile syringe. NRXP preservative free ketamine is being sold by veteran sales representatives, most of whom have decades of experience in the sterile injectable market, and who have existing relationships with purchasers controlling approximately 80% of the current US market.

Lucid Capital Markets has issued a new equity analyst report on NRXP with buy recommendation and a 12 month price target of $49 per share. The full report can be viewed at this direct link: https://www.nrxpharma.com/wp-content/uploads/2026/11/Launched-Preservative-Free-Ketamine-to-Address-Supply-Short.pdf

FDA Approval of Preservative-Free Ketamine

NRXP 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.

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 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.

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.

Commercial Sales Begun for U.S.-Made, Preservative-Free Ketamine Amid Long-Running Shortage.

Certified Sales Force Providing National Coverage with Customers for Approximately 80% of Current U.S. Ketamine Sales.

Lucid Capital Markets Issued Buy Recommendation with $49 Price Target.

FDA Approval of Preservative-Free Ketamine Received Ahead of Schedule.

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

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,

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

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About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for serious central nervous system (CNS) disorders, with particular emphasis on suicidal depression, suicidal bipolar depression, PTSD and chronic pain. The company is developing therapies designed to address significant unmet medical needs, while also building HOPE Therapeutics, a clinical-care platform focused on advanced interventional psychiatric treatment.

Mission

NRx's mission is "to bring hope" through life-saving medicines for people living with unmet medical needs. The company says it seeks to use breakthrough science to make diseases that are difficult or previously untreatable more manageable, with a particular focus on bringing innovative treatments to patients with serious and life-threatening conditions.

NRx Pharmaceuticals, Inc. was legally incorporated in Delaware on September 18, 2017.

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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