NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine
NRx Pharmaceuticals (NASDAQ:NRXP) has filed a patent application for NRX-100, its preservative-free intravenous ketamine formulation designed to treat suicidal depression. The patent, if granted, would provide exclusivity until 2045 and could be listed in the FDA Orange Book. NRX-100's key innovation is its formulation without benzethonium chloride or other preservatives, which have been linked to cytotoxic or neurotoxic effects.
The company has already initiated an NDA filing for NRX-100 and received Fast Track Designation with NRX-101 from the FDA. With a recent FDA fee waiver in place, NRx plans to complete its NDA submission in the current quarter. The patent application includes twenty claims covering pharmaceutical compositions, treatment methods, and manufacturing processes.
NRx Pharmaceuticals (NASDAQ:NRXP) ha depositato una domanda di brevetto per NRX-100, la sua formulazione endovenosa di ketamina senza conservanti, progettata per trattare la depressione suicidaria. Il brevetto, se concesso, garantirebbe l'esclusiva fino al 2045 e potrebbe essere inserito nell'Orange Book della FDA. L'innovazione principale di NRX-100 è la sua formulazione priva di cloruro di benzetonio o altri conservanti, associati a effetti citotossici o neurotossici.
L'azienda ha già avviato la presentazione della NDA per NRX-100 e ha ottenuto la Designazione Fast Track con NRX-101 dalla FDA. Con una recente esenzione dalle tasse FDA, NRx prevede di completare la presentazione della NDA nel trimestre in corso. La domanda di brevetto comprende venti rivendicazioni che riguardano composizioni farmaceutiche, metodi di trattamento e processi di produzione.
NRx Pharmaceuticals (NASDAQ:NRXP) ha presentado una solicitud de patente para NRX-100, su formulación intravenosa de ketamina sin conservantes, diseñada para tratar la depresión suicida. La patente, si se concede, otorgaría exclusividad hasta 2045 y podría ser incluida en el Orange Book de la FDA. La innovación clave de NRX-100 es su formulación sin cloruro de benzetonio u otros conservantes, que se han relacionado con efectos citotóxicos o neurotóxicos.
La compañía ya ha iniciado la presentación de la NDA para NRX-100 y ha recibido la Designación Fast Track con NRX-101 por parte de la FDA. Con una reciente exención de tarifas de la FDA, NRx planea completar la presentación de la NDA en el trimestre actual. La solicitud de patente incluye veinte reivindicaciones que cubren composiciones farmacéuticas, métodos de tratamiento y procesos de fabricación.
NRx Pharmaceuticals (NASDAQ:NRXP)는 자살 우울증 치료를 위해 설계된 방부제 없는 정맥주사용 케타민 제형인 NRX-100에 대한 특허 출원을 제출했습니다. 특허가 승인되면 2045년까지 독점권을 부여받으며 FDA 오렌지북에 등재될 수 있습니다. NRX-100의 주요 혁신은 세포독성 또는 신경독성과 관련된 벤제토늄 클로라이드나 기타 방부제가 없는 제형입니다.
회사는 이미 NRX-100에 대한 NDA 제출을 시작했으며 FDA로부터 NRX-101에 대해 신속 심사 지정(Fast Track Designation)을 받았습니다. 최근 FDA 수수료 면제도 확보하여 NRx는 이번 분기 내 NDA 제출을 완료할 계획입니다. 특허 출원에는 의약 조성물, 치료 방법 및 제조 공정을 포함한 20개의 청구항이 포함되어 있습니다.
NRx Pharmaceuticals (NASDAQ:NRXP) a déposé une demande de brevet pour NRX-100, sa formulation intraveineuse de kétamine sans conservateurs, conçue pour traiter la dépression suicidaire. Le brevet, s'il est accordé, offrirait une exclusivité jusqu'en 2045 et pourrait être inscrit dans l'Orange Book de la FDA. L'innovation clé de NRX-100 réside dans sa formulation sans chlorure de benzéthonium ni autres conservateurs, liés à des effets cytotoxiques ou neurotoxiques.
La société a déjà entamé le dépôt de la NDA pour NRX-100 et a obtenu la désignation Fast Track avec NRX-101 de la FDA. Grâce à une récente exonération des frais de la FDA, NRx prévoit de finaliser son dépôt de NDA au cours du trimestre en cours. La demande de brevet comprend vingt revendications couvrant des compositions pharmaceutiques, des méthodes de traitement et des procédés de fabrication.
NRx Pharmaceuticals (NASDAQ:NRXP) hat eine Patentanmeldung für NRX-100 eingereicht, eine konservierungsmittelfreie intravenöse Ketamin-Formulierung zur Behandlung von suizidaler Depression. Das Patent, sofern erteilt, würde Exklusivität bis 2045 bieten und könnte im FDA Orange Book gelistet werden. Die Hauptinnovation von NRX-100 ist die Formulierung ohne Benzethoniumchlorid oder andere Konservierungsmittel, die mit zytotoxischen oder neurotoxischen Effekten in Verbindung gebracht werden.
Das Unternehmen hat bereits eine NDA-Einreichung für NRX-100 initiiert und erhielt für NRX-101 die Fast Track Designation der FDA. Mit einer kürzlich gewährten Gebührenerlass der FDA plant NRx, die NDA-Einreichung im laufenden Quartal abzuschließen. Die Patentanmeldung umfasst zwanzig Ansprüche, die pharmazeutische Zusammensetzungen, Behandlungsmethoden und Herstellungsverfahren abdecken.
- Patent, if granted, would provide market exclusivity until 2045
- Preservative-free formulation addresses safety concerns associated with benzethonium chloride
- FDA fee waiver received, reducing regulatory costs
- Fast Track Designation already obtained with NRX-101
- NDA submission on track for completion this quarter
- Patent approval not guaranteed
- Product still in clinical-stage, pending FDA approval
- Commercial success uncertain despite potential advantages
Insights
NRx's patent filing for preservative-free ketamine creates potential market exclusivity through 2045, strengthening their suicidal depression treatment pipeline.
NRx Pharmaceuticals' patent application for NRX-100 represents a strategic intellectual property move focused on removing benzethonium chloride from IV ketamine formulations. This application could provide significant commercial protection until 2045 if granted. The Orange Book listing potential is particularly valuable, as it would require generic competitors to either challenge their patent or wait for expiration.
The patent covers twenty claims spanning pharmaceutical compositions, treatment methods, and manufacturing processes. While ketamine itself is decades old, NRx is creating new exclusivity through formulation innovation. By developing room temperature stability without preservatives, they've created a potentially patentable differentiation in a generic drug space.
This filing strategically aligns with their advancing regulatory timeline, including their recently initiated NDA filing and previous Fast Track Designation. The company appears to be pursuing a 505(b)(2) pathway, leveraging ketamine's known efficacy while addressing safety concerns with their preservative-free approach.
For investors, the patent application represents important pipeline progress, though patent review typically takes years and approval isn't guaranteed. The ultimate commercial value depends on both patent grant and FDA approval of their NDA, which they state is on track for completion this quarter following their FDA fee waiver.
NRx's preservative-free ketamine formulation eliminates potential neurotoxicity concerns while targeting the critical unmet need in suicidal depression treatment.
NRx's development of preservative-free ketamine addresses a legitimate safety concern in treating suicidal depression. The current formulation's inclusion of benzethonium chloride raises questions about potential cytotoxic and neurotoxic effects, particularly concerning for vulnerable patients requiring multiple administrations.
Ketamine has emerged as a crucial intervention for treatment-resistant depression and acute suicidality, offering rapid relief compared to traditional antidepressants that typically require weeks to become effective. This time advantage is particularly vital when addressing active suicidal ideation, where immediate intervention can be life-saving.
The company's approach aligns with current regulatory sentiment favoring medications without unnecessary preservatives. Their advancing NDA submission, following a Fast Track Designation for their related product NRX-101, indicates recognition of both the unmet medical need and their approach's promise.
From a clinical perspective, the formulation's potential room temperature stability without preservatives would offer practical advantages for hospital settings. However, the press release doesn't provide specific clinical evidence demonstrating superior safety outcomes compared to existing formulations. The ultimate clinical adoption will depend on the FDA's assessment and whether the reformulation demonstrates meaningful safety advantages in practice.
- Patent expected to be Orange Book listable, if granted
- NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine
- Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression
NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the Company's recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRx advances its commercialization strategy.
"We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need."
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.
For further information: | |
Matthew Duffy | Brian Korb |
Co-CEO, Hope Therapeutics, Inc. | Managing Partner, ASTR Partners |
Chief Business Officer, NRx Pharmaceuticals, Inc. | (917) 653-5122 |
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SOURCE NRx Pharmaceuticals, Inc.
FAQ
What is NRX-100 and how is it different from current ketamine treatments?
When will NRXP's patent for NRX-100 expire if granted?
What is the current regulatory status of NRXP's NRX-100?
How many claims does NRXP's patent application for NRX-100 include?
Has NRXP received any FDA incentives for NRX-100 development?
