NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Receives Notification of US Food and Drug Administration Approval of Suitability Petition for NRx’s Proposed Strength of Preservative-Free Ketamine
NRx Pharmaceuticals (NASDAQ:NRXP) received FDA approval for its Suitability Petition regarding KETAFREE™, a preservative-free ketamine product. This approval enables the company to refile its Abbreviated New Drug Application (ANDA) for a single-patient dose formulation that eliminates the toxic preservative Benzethonium Chloride found in current multi-dose vials.
The development aligns with two key administrative policy objectives: reshoring strategically important sterile drugs and removing toxic preservatives from medications. The current ketamine market is valued at $750 million. Beyond KETAFREE™, NRx aims to develop NRX-100, a non-generic ketamine formulation for treating suicidal depression and PTSD under a New Drug Application.
NRx Pharmaceuticals (NASDAQ:NRXP) ha ottenuto l'approvazione FDA per il suo Suitability Petition riguardo KETAFREE™, un prodotto a base di ketamina senza conservanti. Questa approvazione permette all'azienda di ripresentare la sua Abbreviated New Drug Application (ANDA) per una formulazione a dosaggio per singolo paziente che elimina il conservante tossico Benzethonium Chloride presente nelle attuali fiale multi-dose. Lo sviluppo è in linea con due obiettivi politici amministrativi chiave: riportare in patria farmaci sterili strategicamente importanti e rimuovere conservanti tossici dai medicinali. Il mercato attuale della ketamina è valutato 750 milioni di dollari. Oltre a KETAFREE™, NRx punta a sviluppare NRX-100, una formulazione di ketamina non generica per trattare la depressione suicidabile e PTSD nell'ambito di una New Drug Application.
NRx Pharmaceuticals (NASDAQ:NRXP) obtuvo la aprobación de la FDA para su Suitability Petition respecto a KETAFREE™, un producto de ketamina sin conservantes. Esta aprobación permite a la empresa volver a presentar su Abbreviated New Drug Application (ANDA) para una formulación de dosis para un solo paciente que elimina el conservante tóxico Benzethonium Chloride presente en los viales actuales de dosificación múltiple. El desarrollo se alinea con dos objetivos de política administrativa: volver a producir en casa fármacos estériles estratégicamente importantes y eliminar conservantes tóxicos de los medicamentos. El mercado actual de la ketamina está valorado en 750 millones de dólares. Más allá de KETAFREE™, NRx pretende desarrollar NRX-100, una formulación de ketamina no genérica para tratar la depresión suicidable y el TEPT bajo una New Drug Application.
NRx Pharmaceuticals (NASDAQ:NRXP)가 KETAFREE™에 관한 Suitability Petition에 대해 FDA 승인을 받았습니다. 이는 보존료 없는 케타민 제품입니다. 이 승인은 회사가 현재 다회 투여 병에서 발견되는 독성 보존료 Benzethonium Chloride를 제거한 단일 환자 용량 제형에 대한 Abbreviated New Drug Application(ANDA)을 재제출할 수 있게 합니다. 이 개발은 두 가지 주요 행정 정책 목표와 일치합니다: 전략적으로 중요한 무균 의약품의 자국화와 약물에서 독성 보존료를 제거하는 것. 현재 케타민 시장은 7억 5천만 달러로 평가됩니다. KETAFREE™를 넘어 NRx는 PTSD 및 자살충동 우울증 치료를 위한 제네릭이 아닌 케타민 제형인 NRX-100을 New Drug Application으로 개발하는 것을 목표로 합니다.
NRx Pharmaceuticals (NASDAQ:NRXP) a obtenu l'approbation de la FDA pour sa Suitability Petition concernant KETAFREE™, un produit de kétamine sans conservateurs. Cette approbation permet à l'entreprise de déposer à nouveau son Abbreviated New Drug Application (ANDA) pour une formulation à dose unique destinée à un seul patient qui élimine le conservateur toxique Benzethonium Chloride présent dans les flacons actuels dosés multiples. Le développement s'aligne sur deux objectifs politiques administratifs clés : relocaliser des médicaments stériles importants sur le plan stratégique et éliminer les conservateurs toxiques des médicaments. Le marché actuel de la kétamine est estimé à 750 millions de dollars. Au-delà de KETAFREE™, NRx vise à développer NRX-100, une formulation de kétamine non générique pour traiter la dépression suicidaire et le TSPT sous une New Drug Application.
NRx Pharmaceuticals (NASDAQ:NRXP) erhielt die FDA-Zulassung für seinen Suitability Petition bezüglich KETAFREE™, einem ketaminprodukt ohne Konservierungsstoffe. Diese Zulassung ermöglicht es dem Unternehmen, seinen Abbreviated New Drug Application (ANDA) erneut einzureichen für eine Einzeldosen-Formulierung, die den toxischen Konservierungsstoff Benzethoniumchlorid aus aktuellen Mehrfachdosenvials entfernt. Die Entwicklung entspricht zwei wichtigen administrativen Politikzielen: die inländische Herstellung strategisch wichtiger sterile Arzneimittel und die Entfernung toxischer Konservierungsstoffe aus Medikamenten. Der aktuelle Ketamin-Markt hat einen Wert von 750 Millionen USD. Über KETAFREE™ hinaus will NRx NRX-100 entwickeln, eine nicht-genaue Ketamin-Formulierung zur Behandlung von suizidaler Depression und PTSD unter einer New Drug Application.
NRx Pharmaceuticals (NASDAQ:NRXP) حصلت على موافقة FDA لطلب الملاءمة الخاص بـ KETAFREE™، وهو منتج كيتامين خالٍ من المواد الحافظة. تمنح هذه الموافقة الشركة إمكانية إعادة تقديم طلب الدواء الجديد المختصر (ANDA) لصيغة جرعة واحدة للمريض الواحد تزيل المادة الحافظة السامة بنزيثونيوم كلوريد الموجودة في قوارير الجرعات المتعددة الحالية. التطور يتماشى مع هدفين رئيسيين للسياسة الإدارية: إعادة التصنيع للأدوية المعقمة الاستراتيجية الهامة وإزالة المواد الحافظة السامة من الأدوية. سوق الكيتامين الحالي يقدّر بنحو 750 مليون دولار. بخلاف KETAFREE™، تهدف NRx إلى تطوير NRX-100، صيغة كيتامين غير جنيريكية لعلاج الاكتئاب الانتحاري واضطراب ما بعد الصدمة ضمن طلب دواء جديد.
NRx Pharmaceuticals (NASDAQ:NRXP) 已获得FDA对其Suitability Petition关于KETAFREE™的批准，该产品为无防腐剂的氯胺酮制剂。这一批准使公司能够就单次用药剂型重新提交其缩略新药申请（ANDA），该剂型消除了当前多剂量小瓶中的有毒防腐剂 benzethonium chloride。该开发符合两个关键的行政政策目标：将战略性重要的无菌药物带回国内生产，以及从药物中去除有毒防腐剂。目前的氯胺酮市场价值为7.5亿美元。除了KETAFREE™，NRx还计划开发NRX-100，一种用于治疗自杀性抑郁和PTSD的非仿制氯胺酮制剂，提交新药申请。
- FDA approval of Suitability Petition enables immediate ANDA refiling for KETAFREE™
- Product addresses key policy objectives of drug reshoring and toxin removal
- Targeting established $750 million ketamine market
- Development of additional non-generic formulation (NRX-100) for mental health conditions
- Product still requires full ANDA approval before commercialization
- Will face competition in existing ketamine market
Insights
NRx secures key FDA approval for preservative-free ketamine, unlocking path to $750M market with competitive advantages.
The FDA's granting of NRx Pharmaceuticals' Suitability Petition represents a significant regulatory milestone for the company's KETAFREE™ product. This approval specifically allows NRx to develop a single-patient, preservative-free ketamine formulation - a meaningful improvement over existing multi-dose vials containing Benzethonium Chloride, which is described as a toxic preservative.
What makes this development particularly noteworthy is that it enables the immediate re-filing of the company's Abbreviated New Drug Application (ANDA). The ANDA pathway is designed for generic drug approvals, typically requiring less extensive clinical testing than brand-new drugs, potentially accelerating time-to-market and reducing development costs.
The approved petition specifically addresses the strength (concentration) of the proposed formulation, a critical technical requirement. Current ketamine formulations contain preservatives that allow for multiple doses from a single vial, but introduce potential toxicity concerns. NRx's single-patient approach eliminates this preservative while ensuring appropriate dosing.
This development aligns with two current regulatory priorities: reshoring production of sterile injectable medications and removing potentially harmful additives from pharmaceutical products. The estimated $750 million ketamine market represents a substantial commercial opportunity for NRx if they can successfully execute on this regulatory pathway.
Importantly, this announcement pertains specifically to the generic KETAFREE™ product, which is separate from the company's development of NRX-100, a non-generic ketamine formulation being developed under a New Drug Application for suicidal depression and PTSD.
- Suitability Petition is required for shift from multidose packaging of ketamine to single-patient dose preservative free ketamine
- Granting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx’s patent-pending preservative-free ketamine product
WILMINGTON, Del., Sept. 24, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, announced that it was notified yesterday by the United States Food and Drug Administration that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™). Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the Company’s Abbreviated New Drug Application for KETAFREE™. The Company believes that this proposed product addresses two critical policy objectives as articulated by the current administration: (1) the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and (2) the “Make America Healthy Again” (MAHA) objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership.
The current market for ketamine is estimated at
“Last week, NRx was honored to be selected to attend a ‘listening session’ hosted by the FDA Commissioner, for biotechnology CEOs. We appreciate FDA’s rapid response on the requested Suitability Petition and look forward to bringing our preservative-free presentation of ketamine to the US market at the earliest possible moment,” said Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently had a Suitability Petition granted, allowing re-filing of an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression.
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. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. 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 Chief Business Officer, NRx Pharmaceuticals mduffy@nrxpharma.com | Brian Korb Managing Partner (917) 653-5122 brian.korb@astrpartners.co |
FAQ
What did the FDA approve for NRx Pharmaceuticals (NRXP) regarding ketamine?
How large is the market opportunity for NRx's KETAFREE ketamine product?
What makes NRx's KETAFREE different from existing ketamine products?
What are NRx Pharmaceuticals' plans for ketamine beyond KETAFREE?
How does KETAFREE align with FDA policy objectives?
