NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine

Rhea-AI Summary

NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, a preservative-free IV ketamine formulation. The company aims to address the current US ketamine shortage in a market valued at $750 million, projected to reach $3.35 billion globally by 2034. NRX-100 eliminates benzethonium chloride, a neurotoxic preservative, and will be marketed for all approved uses including anesthesia and pain management. The company plans to file a citizen's petition to remove this toxic preservative from all IV ketamine products. This ANDA complements NRx's ongoing NDA submission for ketamine use in suicidal depression, with PDUFA anticipated in late 2025. The product has received Fast Track Designation and a PDUFA fee waiver, with patent protection sought through 2045.

Positive

• Current ketamine market valued at $750 million with projected growth to $3.35 billion by 2034
• Innovative preservative-free formulation eliminates toxic benzethonium chloride
• FDA granted $4.3 million PDUFA fee waiver and Fast Track Designation
• Patent protection sought through 2045
• Three years of room-temperature shelf stability anticipated
• Potential to capture significant market share in existing ketamine applications

Negative

• Regulatory approval still pending
• Success of citizen's petition to remove benzethonium chloride from all ketamine products not guaranteed
• Competitive market with existing ketamine providers

Insights

Pharmaceutical Regulatory Expert

NRx's ANDA filing for preservative-free ketamine addresses drug shortages and safety concerns while targeting a growing market.

NRx Pharmaceuticals has made a strategic regulatory move by filing an Abbreviated New Drug Application for NRX-100, a preservative-free IV ketamine formulation. This approach tackles two significant market issues simultaneously: addressing the ongoing ketamine shortage in the US while potentially establishing a new safety standard by eliminating benzethonium chloride, a preservative with known neurotoxic properties.

The company's regulatory strategy is multi-faceted and well-structured. By seeking priority review based on the current drug shortage, NRx may accelerate their timeline to market. The planned citizen's petition to remove benzethonium chloride from IV ketamine products could create a significant regulatory advantage if successful, potentially forcing competitors to reformulate their products.

What's particularly notable is how NRx is pursuing multiple regulatory pathways simultaneously - an ANDA for existing ketamine indications while also completing an NDA for the novel indication of suicidal depression. This dual-track approach maximizes their chances of market entry, with the ANDA potentially providing near-term revenue while they pursue the more complex NDA approval.

The FDA's prior decisions to grant both a PDUFA fee waiver ($4.3 million) and Fast Track Designation for a related protocol suggest the agency recognizes the potential public health benefits of NRx's approach. These designations can provide valuable advantages in the review process and signal regulatory receptiveness to their products.

The patent protection through 2045 mentioned for their preservative-free formulation, if granted, would provide substantial exclusivity and market protection well beyond the typical drug lifecycle.

Pharmaceutical Market Analyst

The ketamine market represents a significant opportunity for NRx, with current market size at $750 million and projected growth to $3.35 billion by 2034. This established market provides a foundation for immediate revenue upon approval, unlike many biotech companies developing entirely novel compounds with uncertain market adoption.

NRx's approach is particularly clever from a competitive standpoint. By targeting an existing drug shortage with a potentially safer formulation, they position themselves favorably for both rapid regulatory review and market adoption. Healthcare facilities struggling with ketamine access would likely quickly adopt an available alternative, especially one with safety advantages.

The company's claim about 5.1 million Americans having received ketamine for medical uses demonstrates the substantial patient population, while the mention of "compounded ketamine" usage due to shortage suggests additional unmet demand not captured in official market figures.

The preservative-free formulation creates a meaningful differentiation in a largely commoditized market. If their citizen's petition succeeds in restricting benzethonium chloride use, it could force competitors into costly reformulations or market exits, potentially allowing NRx to capture market share beyond what would be expected for a new entrant.

Most importantly, this product offers dual revenue potential - first from established indications (anesthesia, pain management) through the ANDA pathway, and potentially later from the depression indication through their separate NDA. This creates a stepped approach to market penetration with multiple growth catalysts.

The room-temperature stability for three years mentioned would provide logistical advantages over competitors requiring cold-chain management, potentially allowing for better margins and broader distribution.

• Ketamine faces a current US drug shortage not expected to abate in the near future¹
• Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.²  NRx anticipates marketing ketamine for all approved uses
• Company anticipates priority review based on current and anticipated drug shortage
• NRX-100 to provide innovative, preservative-free IV ketamine formulation to eliminate benzethonium chloride preservative, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs
• The Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from all presentations of ketamine intended for intravenous use
• This filing complements the ongoing NDA submission for NRX-100 in suicidal depression; PDUFA anticipated in late 2025

WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management.

The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. This does not include the widespread use of compounded ketamine by clinics unable to obtain manufactured drug. NRx aims to capture a significant share of that existing market. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime³, a number that continues to grow with increased clinical focus on this important medication. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacist with no short-term abatement. Accordingly, NRx is seeking priority review from FDA.

The Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. Management believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of closely related benzalkonium chloride in current drug products. Preservatives were originally added to sterile injectable products in an era when a single vial of medication was used to treat multiple patients, a practice no longer allowed in US hospitals. NRx has demonstrated that there is no need for such preservatives to maintain stability and sterility in ketamine presentations intended for single-patient use. Should the citizen's petition be granted, all formulations of ketamine sold in the US could face a regulatory requirement to be preservative free.

Today's filing supplements the New Drug Application currently being completed by the Company to extend the labeled indications of ketamine to include the treatment of suicidal depression. The Company anticipates submitting clinical trials data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy.

"This submission comes at a time when the demand for ketamine in the US market is rapidly increasing and the available supply is inadequate. We at NRx believe that safer, preservative-free formulations of ketamine will be increasingly preferred by physicians, patients, and regulators in this large and growing market." said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "NRX-100 is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility. We have filed a US patent on our novel, preservative-free formulation, which anticipates three years of room-temperature shelf stability."

In April 2025, the FDA granted a waiver of the $4.3 million NDA fee under the PDUFA, recognizing both the product's public health value and NRx's qualification under small business provisions. NRX-100 was previously granted Fast Track Designation in a protocol with NRX-101. With regulatory filings underway, patent protection sought through 2045, and a growing body of clinical and technical validation, NRx believes NRX-100 is well-positioned to become a next-generation standard in both the emerging mental health market and the current $750 million ketamine market, offering physicians and patients a safer, more reliable alternative to legacy ketamine products.

About NRx Pharmaceuticals, Inc.
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 bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential as a treatment for complicated UTI.

NRx has recently initiated a New Drug Application filing for NRX-100 (preservative free IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality and has filed a patent for this novel formulation with the US Patent and Trademark Office.

About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.

Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, whether the USPTO approves the Company's patent, and whether the FDA will approve the Company's NDA. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:
Matthew Duffy Co-CEO, Hope Therapeutics, Chief Business Officer, NRx Pharmaceuticals, Inc. mduffy@nrxpharma.com	Brian Korb Managing Partner, astr partners (917) 653-5122 brian.korb@astrpartners.com

¹ https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=391
² https://www.factmr.com/report/injectable-ketamine-market
³ https://www.radars.org/system/publications/NMURx%20Ketamine%20Use%20Poster_fin2.pdf

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SOURCE NRx Pharmaceuticals, Inc.

FAQ

What is NRx Pharmaceuticals' new ketamine drug application (ANDA) for?

NRx Pharmaceuticals filed an ANDA for NRX-100, a preservative-free IV ketamine formulation, intended for use in approved indications like anesthesia and pain management.

What is the market size for ketamine that NRXP is targeting?

The current ketamine market is estimated at $750 million and is projected to grow to $3.35 billion globally by 2034.

What makes NRX-100 different from existing ketamine products?

NRX-100 is a preservative-free formulation that eliminates benzethonium chloride, a known neurotoxic and cytotoxic substance, while maintaining three years of room-temperature shelf stability.

When is the PDUFA date for NRXP's ketamine application for suicidal depression?

The PDUFA date for NRx's ketamine application for suicidal depression is anticipated in late 2025.

Has NRXP received any special FDA designations for NRX-100?

Yes, NRX-100 has received Fast Track Designation and a waiver of the $4.3 million PDUFA fee from the FDA.