NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of a Citizen Petition with the US Food and Drug Administration Seeking Removal of Benzethonium Chloride from Ketamine Products
NRx Pharmaceuticals (NASDAQ:NRXP) has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the United States. The company emphasizes that BZT is a toxic preservative not recognized as safe by the FDA for parenteral products or topical use.
In June 2025, NRx filed an Abbreviated New Drug Application for a preservative-free ketamine preparation, demonstrating 3-year room temperature stability. The company has established US-based manufacturing and is pursuing approval for ketamine use in treating suicidal depression through FDA's National Priority Voucher Program.
This initiative aligns with federal priorities to eliminate toxic additives from the US drug supply and promote domestic pharmaceutical manufacturing.
NRx Pharmaceuticals (NASDAQ:NRXP) ha presentato una Petizione dei Cittadini alla FDA chiedendo la rimozione del Cloruro di Benzetonio (BZT) da tutti i prodotti a base di ketamina venduti negli Stati Uniti. L'azienda sottolinea che il BZT è un conservante tossico non riconosciuto dalla FDA come sicuro per prodotti parenterali o per uso topico.
Nel giugno 2025, NRx ha presentato una Domanda Abbreviata di Nuovo Farmaco per una preparazione di ketamina senza conservanti, dimostrando una stabilità di 3 anni a temperatura ambiente. L'azienda ha stabilito una produzione negli Stati Uniti e sta perseguendo l'approvazione per l'uso della ketamina nel trattamento della depressione suicidaria attraverso il Programma Nazionale di Voucher Prioritari della FDA.
Questa iniziativa è in linea con le priorità federali di eliminare additivi tossici dalla fornitura di farmaci negli Stati Uniti e di promuovere la produzione farmaceutica nazionale.
NRx Pharmaceuticals (NASDAQ:NRXP) ha presentado una Petición Ciudadana ante la FDA solicitando la eliminación del Cloruro de Benzetonio (BZT) de todos los productos de ketamina vendidos en Estados Unidos. La compañía destaca que el BZT es un conservante tóxico no reconocido como seguro por la FDA para productos parenterales o uso tópico.
En junio de 2025, NRx presentó una Solicitud Abreviada de Nuevo Medicamento para una preparación de ketamina sin conservantes, demostrando estabilidad a temperatura ambiente por 3 años. La empresa ha establecido fabricación en EE.UU. y busca la aprobación para el uso de ketamina en el tratamiento de la depresión suicida a través del Programa Nacional de Vales Prioritarios de la FDA.
Esta iniciativa se alinea con las prioridades federales de eliminar aditivos tóxicos del suministro de medicamentos en EE.UU. y promover la fabricación farmacéutica nacional.
NRx Pharmaceuticals (NASDAQ:NRXP)는 미국에서 판매되는 모든 케타민 제품에서 벤제토늄 클로라이드(BZT)를 제거해 달라는 시민 청원서를 FDA에 제출했습니다. 회사는 BZT가 주사제나 국소용 제품에 대해 FDA가 안전하다고 인정하지 않은 독성 방부제임을 강조합니다.
2025년 6월, NRx는 방부제가 없는 케타민 제제를 위한 간소화 신약 신청서를 제출했으며, 실온에서 3년간 안정성을 입증했습니다. 회사는 미국 내 제조 시설을 구축했으며, FDA의 국가 우선권 바우처 프로그램을 통해 자살 우울증 치료용 케타민 승인도 추진 중입니다.
이 이니셔티브는 독성 첨가물을 미국 의약품 공급망에서 제거하고 국내 제약 제조를 촉진하려는 연방 정부의 우선 과제와 일치합니다.
NRx Pharmaceuticals (NASDAQ:NRXP) a déposé une pétition citoyenne auprès de la FDA demandant le retrait du Chlorure de Benzéthonium (BZT) de tous les produits à base de kétamine vendus aux États-Unis. L'entreprise souligne que le BZT est un conservateur toxique non reconnu comme sûr par la FDA pour les produits parentéraux ou d'usage topique.
En juin 2025, NRx a soumis une Demande Abrégée de Nouveau Médicament pour une préparation de kétamine sans conservateurs, démontrant une stabilité de 3 ans à température ambiante. La société a établi une production basée aux États-Unis et poursuit l'approbation de l'utilisation de la kétamine pour le traitement de la dépression suicidaire via le Programme National de Bons de Priorité de la FDA.
Cette initiative s'aligne sur les priorités fédérales visant à éliminer les additifs toxiques de l'approvisionnement en médicaments aux États-Unis et à promouvoir la fabrication pharmaceutique nationale.
NRx Pharmaceuticals (NASDAQ:NRXP) hat eine Bürgerpetition bei der FDA eingereicht und fordert die Entfernung von Benzethoniumchlorid (BZT) aus allen in den USA verkauften Ketaminprodukten. Das Unternehmen betont, dass BZT ein toxischer Konservierungsstoff ist, der von der FDA für parenterale Produkte oder zur topischen Anwendung nicht als sicher anerkannt wird.
Im Juni 2025 reichte NRx einen Abgekürzten Zulassungsantrag für ein neues Medikament für eine konservierungsmittelfreie Ketaminpräparation ein, die eine dreijährige Stabilität bei Raumtemperatur nachweist. Das Unternehmen hat eine Produktionsstätte in den USA aufgebaut und strebt die Zulassung der Ketaminanwendung zur Behandlung von suizidaler Depression im Rahmen des National Priority Voucher Program der FDA an.
Diese Initiative entspricht den bundesstaatlichen Prioritäten, toxische Zusatzstoffe aus der US-Arzneimittelversorgung zu entfernen und die inländische Pharmaherstellung zu fördern.
- None.
- Current ketamine products contain potentially toxic preservative BZT
- Awaiting FDA generic approval before commercialization
- Ketamine's use in suicidal depression is currently not a labeled indication
Insights
NRx's FDA petition against benzethonium chloride in ketamine could strengthen their competitive position if successful, while addressing legitimate safety concerns.
NRx Pharmaceuticals has made a strategic regulatory move by filing a Citizen Petition with the FDA requesting the removal of benzethonium chloride (BZT) from all ketamine products in the US. This preservative has already been prohibited in hand cleansers and topical antiseptics due to safety concerns, creating a strong precedent for this petition.
What makes this particularly significant is that NRx has simultaneously filed an Abbreviated New Drug Application (ANDA) for their own preservative-free ketamine formulation, demonstrating 3-year room temperature stability and sterility. They've also filed a patent on their preservative-free process, positioning themselves uniquely in the market if the FDA takes action.
The timing is particularly noteworthy as ketamine's use has evolved substantially from its original purpose as an anesthetic to being widely administered repeatedly for off-label treatment of suicidal depression and PTSD. This change in usage pattern makes the safety profile of preservatives more relevant, as patients now receive multiple exposures rather than one-time administration.
NRx is also pursuing a labeled indication for ketamine in suicidal depression through the FDA's National Priority Voucher Program, which could significantly expand their market opportunity. Their establishment of US-based high-volume manufacturing while awaiting generic approval demonstrates their confidence in eventual regulatory success and aligns with current governmental priorities to re-shore pharmaceutical production.
If successful, this two-pronged approach—removing a competitor's preservative while offering an alternative solution—could position NRx advantageously in what appears to be a growing ketamine market, particularly for mental health applications.
- Sterile ketamine products currently for sale in
the United States contain benzethonium chloride, a preservative with known toxicity that is not Generally Recognized as Safe and Effective by the US Food and Drug Administration - FDA has previously prohibited the use of benzethonium chloride in hand cleansers and topical antiseptics
- Substantial precedent exists for removal of toxic preservatives from vaccines, eyedrops, and other pharmaceutical products
- The Company has filed data with FDA that documents the long-term stability and sterility of preservative-free ketamine for intravenous use
In June 2025 NRx filed an Abbreviated New Drug Application with the FDA for a preservative-free preparation of ketamine, demonstrating support for 3 year room temperature stability and sterility. NRx has similarly filed a patent on its preservative-free process, in light of prior art that suggested BZT was required for long term stability and sterility. The Company has instituted US-based high volume manufacture, while it awaits generic approval. The Company is additionally seeking a labeled indication for the use of ketamine to treat suicidal depression through the recently-announced FDA Commissioner's National Priority Voucher Program.
"At its introduction in the 1970s, ketamine was developed as an anesthetic and was never intended to be administered repeatedly to patients," said Dr. Jonathan Javitt, CEO of NRx Pharmaceuticals. "Ketamine is now widely used on a repeated basis as the only currently marketed drug that has shown benefit in treating suicidal depression and PTSD, although this is currently not a labeled indication. Hence, patients who receive intravenous ketamine on a repeated basis are exposed to a known toxic preservative that cannot be used today in hand cleaner, antiseptics, and other topical products. The European Medicines Agency has warned against its use.2 We believe that our Citizen Petition aligns with priorities articulated by current leadership of the US Department of Health and Human Services to remove potentially toxic additives and preservatives from the US Food and Drug supply and to re-shore the US Drug Supply."
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. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia.
NRx has recently filed an Abbreviated New Drug Application (ANDA) for preservative-free ketamine and initiated a New Drug Application filing for NRX-100 (IV ketamine) under the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. The filing is 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.
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. 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, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. 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 | Brian Korb | |
Chief Business Officer, NRx Pharmaceuticals | Managing Partner | |
(917) 653-5122 | ||
1
2 European Medicines Agency (EMA). (2020). Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use [PDF]. EMA. https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzalkonium-chloride-used-excipient-medicinal-products-human-use_en.pdf
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-filing-of-a-citizen-petition-with-the-us-food-and-drug-administration-seeking-removal-of-benzethonium-chloride-from-ketamine-products-302520439.html
SOURCE NRx Pharmaceuticals, Inc.
FAQ
What is NRx Pharmaceuticals (NRXP) requesting in their FDA Citizen Petition?
Why is NRXP concerned about Benzethonium Chloride in ketamine products?
What alternative has NRXP developed for ketamine preservation?
What new indication is NRXP seeking for their ketamine product?
Where will NRXP manufacture their preservative-free ketamine?
