NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression
NRx Pharmaceuticals (NASDAQ: NRXP) has received an FDA waiver for the $4.3 million filing fee for its New Drug Application for NRX-100, a preservative-free ketamine treatment for suicidal depression. The company plans to complete the NDA filing by Q2 2025.
The drug's key innovation is its preservative-free formulation, avoiding benzethonium chloride, which has potential neurotoxic effects. NRX-100 has demonstrated two-year shelf life stability and could receive long-term exclusivity upon FDA approval.
Clinical trials have shown ketamine's superiority over placebo and active comparators in treating depression and suicidal ideation. The FDA's fee waiver, granted to Small Business Entities and drugs deemed necessary for Public Health, enables NRx to proceed with its application using existing resources. The company aims to make this potentially life-saving therapy accessible through insurance coverage, as current ketamine treatments for depression are not FDA-approved and require out-of-pocket payment.
NRx Pharmaceuticals (NASDAQ: NRXP) ha ottenuto una deroga dalla FDA per la tassa di presentazione di 4,3 milioni di dollari relativa alla sua Domanda di Nuovo Farmaco (NDA) per NRX-100, un trattamento a base di ketamina senza conservanti per la depressione suicidaria. L'azienda prevede di completare la presentazione dell'NDA entro il secondo trimestre del 2025.
L'innovazione principale del farmaco è la sua formulazione priva di conservanti, evitando il cloruro di benzetonio, che può avere effetti neurotossici. NRX-100 ha dimostrato una stabilità di conservazione di due anni e potrebbe ottenere un'esclusività a lungo termine una volta approvato dalla FDA.
Gli studi clinici hanno evidenziato la superiorità della ketamina rispetto al placebo e ai trattamenti attivi nel trattamento della depressione e delle idee suicidarie. La deroga della tassa FDA, concessa alle Piccole Imprese e ai farmaci considerati necessari per la salute pubblica, consente a NRx di procedere con la domanda utilizzando le risorse attuali. L'azienda mira a rendere questa terapia potenzialmente salvavita accessibile tramite copertura assicurativa, dato che i trattamenti attuali a base di ketamina per la depressione non sono approvati dalla FDA e richiedono pagamenti diretti da parte dei pazienti.
NRx Pharmaceuticals (NASDAQ: NRXP) ha recibido una exención de la FDA para la tarifa de presentación de 4,3 millones de dólares de su Solicitud de Nuevo Medicamento (NDA) para NRX-100, un tratamiento con ketamina sin conservantes para la depresión suicida. La empresa planea completar la presentación de la NDA para el segundo trimestre de 2025.
La innovación clave del medicamento es su formulación sin conservantes, evitando el cloruro de benzetonio, que puede tener efectos neurotóxicos. NRX-100 ha demostrado estabilidad en estantería por dos años y podría obtener exclusividad a largo plazo tras la aprobación de la FDA.
Los ensayos clínicos han demostrado la superioridad de la ketamina sobre placebo y comparadores activos en el tratamiento de la depresión y las ideas suicidas. La exención de la tarifa de la FDA, otorgada a Pequeñas Empresas y medicamentos considerados necesarios para la Salud Pública, permite a NRx continuar con su solicitud utilizando los recursos existentes. La empresa busca hacer que esta terapia potencialmente salvavidas sea accesible mediante cobertura de seguro, ya que los tratamientos actuales con ketamina para la depresión no están aprobados por la FDA y requieren pago directo por parte del paciente.
NRx Pharmaceuticals (NASDAQ: NRXP)는 자살 우울증 치료제인 NRX-100의 신약 신청서(New Drug Application, NDA) 제출 수수료 430만 달러에 대해 FDA 면제를 받았습니다. 이 회사는 2025년 2분기까지 NDA 제출을 완료할 계획입니다.
이 약물의 주요 혁신은 방부제가 없는 조성으로, 신경독성 가능성이 있는 벤제토늄 클로라이드를 배제했다는 점입니다. NRX-100은 2년간의 저장 안정성을 입증했으며 FDA 승인 시 장기 독점권을 받을 수 있습니다.
임상 시험에서 케타민은 우울증과 자살 충동 치료에 있어 위약 및 활성 비교 약물보다 우수한 효과를 보였습니다. FDA의 수수료 면제는 중소기업과 공중 보건에 필요한 약물에 부여되며, NRx가 기존 자원을 활용해 신청 절차를 진행할 수 있게 합니다. 회사는 현재 FDA 승인을 받지 않아 환자가 직접 비용을 부담하는 케타민 우울증 치료제를 보험 적용을 통해 접근 가능하게 만드는 것을 목표로 하고 있습니다.
NRx Pharmaceuticals (NASDAQ : NRXP) a obtenu une exonération de la FDA pour les frais de dépôt de 4,3 millions de dollars liés à sa demande de nouveau médicament (NDA) pour NRX-100, un traitement à base de kétamine sans conservateurs destiné à la dépression suicidaire. La société prévoit de finaliser le dépôt de la NDA d'ici le deuxième trimestre 2025.
L'innovation clé du médicament réside dans sa formulation sans conservateurs, évitant le chlorure de benzéthonium, qui présente des effets neurotoxiques potentiels. NRX-100 a démontré une stabilité de conservation de deux ans et pourrait bénéficier d'une exclusivité à long terme après approbation par la FDA.
Les essais cliniques ont montré la supériorité de la kétamine par rapport au placebo et aux comparateurs actifs dans le traitement de la dépression et des idées suicidaires. L'exonération des frais par la FDA, accordée aux petites entreprises et aux médicaments jugés nécessaires à la santé publique, permet à NRx de poursuivre sa demande avec les ressources existantes. La société vise à rendre cette thérapie potentiellement salvatrice accessible via une couverture d'assurance, car les traitements actuels à base de kétamine pour la dépression ne sont pas approuvés par la FDA et nécessitent un paiement direct par les patients.
NRx Pharmaceuticals (NASDAQ: NRXP) hat von der FDA eine Gebührenerlassung für die 4,3 Millionen Dollar Anmeldegebühr seiner Zulassungsanmeldung (NDA) für NRX-100 erhalten, eine konservierungsmittelfreie Ketamin-Behandlung bei suizidaler Depression. Das Unternehmen plant, die NDA-Einreichung bis zum zweiten Quartal 2025 abzuschließen.
Die wesentliche Innovation des Medikaments ist seine konservierungsmittelfreie Formulierung, die Benzethoniumchlorid vermeidet, das potenziell neurotoxisch wirkt. NRX-100 hat eine Haltbarkeitsstabilität von zwei Jahren gezeigt und könnte bei FDA-Zulassung eine langfristige Exklusivität erhalten.
Klinische Studien haben die Überlegenheit von Ketamin gegenüber Placebo und aktiven Vergleichssubstanzen bei der Behandlung von Depression und suizidalen Gedanken gezeigt. Der von der FDA gewährte Gebührenerlass, der kleinen Unternehmen und Arzneimitteln, die für die öffentliche Gesundheit notwendig sind, gewährt wird, ermöglicht es NRx, den Antrag mit den vorhandenen Mitteln weiterzuführen. Das Unternehmen möchte diese potenziell lebensrettende Therapie durch Versicherungsdeckung zugänglich machen, da derzeitige Ketamin-Behandlungen für Depressionen nicht von der FDA zugelassen sind und aus eigener Tasche bezahlt werden müssen.
- FDA grants $4.3M filing fee waiver for NRX-100 NDA submission, reducing cash burn
- Company has sufficient resources to complete NDA filing by Q2 2025
- NRX-100 has patent-pending process for potential long-term market exclusivity
- FDA Fast Track designation already granted for suicidal bipolar depression treatment
- Potential for insurance reimbursement coverage if FDA approval is obtained
- Product not yet FDA approved or commercially available
- Current ketamine treatments not reimbursed by most insurance carriers
- Faces competition from existing ketamine treatments in the market
Insights
FDA fee waiver saves NRx $4.3M and supports NDA timeline, positioning preservative-free ketamine for suicidal depression treatment.
The FDA's $4.3 million filing fee waiver for NRx's New Drug Application represents a significant regulatory milestone. This waiver, granted to Small Business Entities or for drugs deemed necessary for public health, eliminates a substantial financial barrier in the approval pathway. The company now has a clearly defined regulatory timeline with NDA submission targeted for Q2 2025 and potential PDUFA decision by year-end.
NRX-100's development addresses a critical differentiation in the ketamine market. Current ketamine formulations contain benzethonium chloride as a preservative, which has never been safety-tested for repeated use and belongs to a class of compounds shown to be neurotoxic in certain applications. NRx has demonstrated a two-year shelf life with their preservative-free formulation, supporting their patent-pending process and potential market exclusivity.
The existing Fast Track designation (granted in 2018) for NRX-100/NRX-101 for suicidal bipolar depression underscores the FDA's recognition of the unmet medical need. The current treatment landscape for suicidal depression is notably limited, with electroconvulsive therapy being the only FDA-approved option.
The recent supportive statements from the Secretary of Health and Human Services regarding psychedelic drugs for depression and PTSD suggest an increasingly favorable regulatory environment for ketamine-based therapies, which could positively influence the review process.
$4.3M FDA fee waiver strengthens NRx's financial position, enabling NDA completion with existing resources.
The FDA's
The company's explicit confirmation that it can complete the NDA filing with "currently-available corporate resources" provides important near-term financial visibility. This reduces immediate dilution risk for shareholders that would typically accompany pre-submission financing rounds. The defined timeline - NDA filing by Q2 2025 with potential approval by year-end - creates clear financial milestones for evaluating execution.
NRX-100's market positioning offers economic advantages if approved. Current ketamine depression treatments operate largely as cash-pay models without insurance coverage due to lack of FDA approval for this indication. By pursuing formal FDA approval for suicidal depression, NRx could potentially access insurance reimbursement channels, significantly expanding the addressable market beyond patients who can afford out-of-pocket expenses.
The patent-pending process for the preservative-free formulation creates potential for long-term market exclusivity. Additionally, the differentiation from existing ketamine products that contain potentially neurotoxic preservatives provides both a safety advantage and a competitive market positioning.
- Waiver exempts NRx from paying a
$4.3 million - Company is on track for Q2 2025 completion of NDA filing and PDUFA date by year end with currently available corporate resources
- NRX-100, together with NRX-101, was granted Fast Track designation by FDA for treatment of suicidal bipolar depression in 2018
- Company notes recent statements by Secretary of Health and Human Services regarding the public health importance of approving psychedelic drugs such as ketamine to treat suicidal depression and PTSD
NRX-100 is a preservative-free preparation of ketamine in a single-patient presentation. Currently-available forms of ketamine contain preservative – benzethonium chloride – the safety of which has never been demonstrated for repeated use. The preservative was added in the 1970s when ketamine was originally formulated as an anesthetic and the practice at the time was to package anesthetic drugs in multi-use vials that required a preservative to maintain sterility. Although benzethonium chloride has not demonstrated toxicity in anesthesia, this class of preservatives has been shown to be neurotoxic and cytotoxic to the tissues of the eye when incorporated in eye drops. NRx has now demonstrated stability and sterility sufficient to maintain more than two years of shelf life in a preservative-free presentation. This patent-pending process is anticipated to yield long-term exclusivity should NRX-100 be approved by the FDA.
As previously announced, NRx will be submitting data from controlled clinical trials that demonstrate ketamine to be superior to both a placebo and an active comparator, as well as either non-inferior or superior to electroshock therapy in treating various forms of depression, including patients with active suicidal ideation. Although ketamine in various forms is increasingly used to treat depression and related disorders, it is approved by FDA only for use as an anesthetic and, therefore, not reimbursed by most insurance carriers for treatment of suicidality or depression. By applying for FDA approval to treat suicidal depression with NRX-100, the Company hopes to make this potentially life-saving therapy available to all Americans, not just those who are able to pay out of pocket.
The Company notes recent statements by the Secretary of Health and Human Services supporting the importance of psychedelic drugs to treat severe depression and PTSD. Ketamine is believed to have a beneficial effect through its role in blocking the NMDA receptor of the brain and causing increased levels of beneficial neurotransmitters in the brain, with resulting formation of new brain cell connections (synapses).
"We at NRx are encouraged by this important fee waiver from the FDA and by the posture expressed by the new leadership of the Department of Health and Human Services in support of new psychedelic drugs to treat the more than 3 million Americans who consider suicide every year and currently have no approved treatment other than electroshock therapy," said Dr. Jonathan Javitt, CEO and Chairman of NRx Pharmaceuticals. "NRx aims to make its preservative-free ketamine available to physicians who care for patients with suicidal depression and PTSD."
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 to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (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.
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 Statement
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 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-fda-award-of-filing-fee-waiver-for-upcoming-nrx-100-preservative-free-ketamine-new-drug-application-to-treat-patients-with-suicidal-depression-302442417.html
SOURCE NRx Pharmaceuticals, Inc.
FAQ
What is the FDA fee waiver amount for NRXP's NRX-100 ketamine drug application in 2025?
When will NRXP submit their NDA for NRX-100 ketamine treatment?
How is NRXP's NRX-100 ketamine different from existing ketamine treatments?
What clinical trial results support NRXP's NRX-100 ketamine treatment?
Why is NRXP seeking FDA approval for NRX-100 ketamine?
