NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression
NRx Pharmaceuticals (NASDAQ:NRXP) has received FDA Fast Track designation for NRX-100, its intravenous ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. This expanded designation represents a 10-fold increase in the addressable population compared to its 2017 designation.
Clinical trials demonstrated significant efficacy, with 55% response rate in suicidal patients compared to 30% for active comparator, and 63% achieving full remission from suicidal ideation within three days versus 31% for placebo. The company targets a $3+ billion market opportunity, addressing approximately 13 million Americans who consider suicide annually.
NRX-100 is the first preservative-free ketamine formulation filed with FDA, offering potential three-year room temperature shelf life. The company has completed CMC information filing and is pursuing a Commissioner's National Priority Voucher to expedite review.
NRx Pharmaceuticals (NASDAQ:NRXP) ha ottenuto la designazione Fast Track dalla FDA per NRX-100, il suo trattamento endovenoso a base di ketamina per l'ideazione suicidaria in pazienti con depressione, inclusa la depressione bipolare. Questa designazione ampliata rappresenta un aumento di 10 volte della popolazione potenzialmente trattabile rispetto alla designazione del 2017.
Gli studi clinici hanno mostrato un'efficacia significativa: un tasso di risposta del 55% nei pazienti con ideazione suicidaria rispetto al 30% del comparatore attivo, e il 63% ha raggiunto la remissione completa dall'ideazione suicidaria entro tre giorni contro il 31% con placebo. L'azienda punta a un'opportunità di mercato superiore a 3 miliardi di dollari, rivolgendo l'intervento a circa 13 milioni di americani che ogni anno prendono in considerazione il suicidio.
NRX-100 è la prima formulazione di ketamina priva di conservanti presentata alla FDA e offre la potenziale possibilità di una shelf-life di tre anni a temperatura ambiente. L'azienda ha completato la presentazione delle informazioni CMC e sta richiedendo un Commissioner's National Priority Voucher per accelerare la revisione.
NRx Pharmaceuticals (NASDAQ:NRXP) ha recibido la designación Fast Track de la FDA para NRX-100, su tratamiento intravenoso con ketamina para ideación suicida en pacientes con depresión, incluida la depresión bipolar. Esta designación ampliada supone un aumento de 10 veces en la población susceptible de tratamiento respecto a la designación de 2017.
Los ensayos clínicos mostraron una eficacia significativa: un 55% de tasa de respuesta en pacientes con ideación suicida frente al 30% con el comparador activo, y un 63% alcanzó la remisión completa de la ideación suicida en tres días frente al 31% con placebo. La compañía calcula una oportunidad de mercado superior a 3.000 millones de dólares, atendiendo a aproximadamente 13 millones de estadounidenses que cada año contemplan el suicidio.
NRX-100 es la primera formulación de ketamina sin conservantes presentada a la FDA y podría ofrecer una vida útil a temperatura ambiente de hasta tres años. La compañía ha completado la presentación de la información CMC y está solicitando un Commissioner's National Priority Voucher para agilizar la revisión.
NRx Pharmaceuticals (NASDAQ:NRXP)는 자살 사고가 있는 우울증(양극성 우울증 포함) 환자를 위한 정맥주사 케타민 치료제 NRX-100에 대해 FDA의 Fast Track 지정을 받았습니다. 이번 지정 확대는 2017년 지정과 비교해 치료 대상 인구가 약 10배 증가
임상시험에서 유의한 효능이 확인되었으며, 자살 사고 환자에서 55%의 반응률을 보였고 활성 비교군은 30%였습니다. 또한 63%는 3일 이내에 자살 사고에서 완전 관해를 달성했으며 위약군은 31%였습니다. 회사는 연간 자살을 고려하는 약 1300만 명의 미국인을 대상으로 30억 달러 이상의 시장 기회를 목표로 하고 있습니다.
NRX-100은 FDA에 제출된 최초의 무방부제 케타민 제형으로, 상온에서 3년의 잠재적 유통기한을 제공할 수 있습니다. 회사는 CMC 정보 제출을 완료했으며 심사 가속화를 위해 Commissioner's National Priority Voucher를 신청 중입니다.
NRx Pharmaceuticals (NASDAQ:NRXP) a obtenu la désignation Fast Track de la FDA pour NRX-100, son traitement intraveineux à base de kétamine destiné aux patients déprimés présentant des idées suicidaires, y compris la dépression bipolaire. Cette désignation élargie représente une augmentation d'un facteur 10 de la population ciblée par rapport à celle de 2017.
Les essais cliniques ont montré une efficacité significative : un taux de réponse de 55% chez les patients suicidaires contre 30% pour le comparateur actif, et 63% ont atteint une rémission complète des idées suicidaires en trois jours contre 31% avec placebo. La société vise une opportunité de marché supérieure à 3 milliards de dollars, en s'adressant à environ 13 millions d'Américains qui envisagent le suicide chaque année.
NRX-100 est la première formulation de kétamine sans conservateurs déposée auprès de la FDA et pourrait offrir une durée de conservation à température ambiante de trois ans. La société a finalisé le dépôt des informations CMC et sollicite un Commissioner's National Priority Voucher pour accélérer l'examen.
NRx Pharmaceuticals (NASDAQ:NRXP) hat für NRX-100, sein intravenöses Ketamin-Präparat zur Behandlung von suizidalen Gedanken bei Patienten mit Depression, einschließlich bipolarer Depression, den Fast-Track-Status der FDA erhalten. Diese erweiterte Zulassung bedeutet eine zehnfache Vergrößerung der ansprechbaren Patientengruppe im Vergleich zur Zulassung von 2017.
Klinische Studien zeigten eine deutliche Wirksamkeit: eine Anspruchsantwortrate von 55% bei suizidalen Patienten gegenüber 30% beim aktiven Vergleichsarm, und 63% erreichten innerhalb von drei Tagen eine vollständige Remission der suizidalen Gedanken gegenüber 31% unter Placebo. Das Unternehmen peilt eine Marktchance von über 3 Milliarden US-Dollar an und spricht damit rund 13 Millionen Amerikaner an, die jährlich Suizid in Erwägung ziehen.
NRX-100 ist die erste konservierungsmittelfreie Ketamin-Formulierung, die bei der FDA eingereicht wurde, und könnte eine Haltbarkeit von drei Jahren bei Raumtemperatur ermöglichen. Das Unternehmen hat die CMC-Unterlagen eingereicht und beantragt einen Commissioner's National Priority Voucher, um die Prüfung zu beschleunigen.
- FDA Fast Track designation expands addressable market 10-fold to 13 million Americans
- Strong clinical trial results showing 63% remission rate from suicidal ideation in 3 days
- First preservative-free ketamine formulation with potential 3-year shelf life
- Targets substantial $3+ billion market opportunity in Suicidal Depression
- Enhanced FDA communication and potential for Priority/Rolling Review
- Already reimbursed by Veterans Affairs and Department of Defense
- Current ketamine treatments not reimbursed by most insurance carriers
- Product still requires FDA approval for commercial launch
- Competing ketamine products already in market, though with preservatives
Insights
FDA Fast Track designation for NRX-100 significantly expands market opportunity and accelerates regulatory pathway for NRx's suicide treatment.
This FDA Fast Track designation represents a substantial regulatory milestone for NRx Pharmaceuticals with several key implications. The designation for NRX-100 (ketamine) now covers suicidal ideation in all depression patients, not just bipolar depression, expanding the addressable population 10-fold to potentially 13 million Americans who consider suicide annually.
The FDA's determination that NRX-100 addresses an unmet medical need is particularly significant because it satisfies a crucial requirement for the Commissioner's National Priority Voucher (CNPV) program and potentially Accelerated Approval. These pathways could dramatically compress the approval timeline.
The clinical data supporting this designation appears robust – trials showed
NRx's preservative-free formulation provides a competitive advantage over existing ketamine products containing Benzethonium Chloride. The company has established US-based manufacturing and submitted complete CMC information, positioning them to potentially capture a share of what they estimate as a
With Fast Track benefits including enhanced FDA communication, potential priority review, and rolling review, NRx has significantly derisked and accelerated their regulatory pathway for what could be a breakthrough therapy addressing a critical public health crisis.
NRx's Fast Track designation unlocks massive market opportunity addressing 13M potential patients in the underserved suicide prevention market.
The expansion of NRX-100's addressable population represents a dramatic market opportunity shift. By obtaining Fast Track designation for suicidal ideation across all depression types (not just bipolar depression), NRx has positioned its ketamine formulation to potentially serve 13 million Americans who consider suicide annually—a 10-fold increase from their previous addressable market.
This positions NRx to potentially disrupt the
The reimbursement landscape is particularly compelling. While ketamine treatments for depression are largely cash-pay currently (limiting accessibility), FDA approval would likely trigger insurance coverage, dramatically expanding market penetration. NRx already notes that the VA and Department of Defense reimburse intravenous ketamine for their beneficiaries, providing an established reimbursement precedent.
Their preservative-free formulation creates a differentiated product profile against existing ketamine options. By eliminating Benzethonium Chloride (BZT), they've not only improved the safety profile but created potential regulatory leverage through their Citizen Petition seeking BZT removal from all IV ketamine products.
With US-based manufacturing already established and Fast Track benefits accelerating their timeline, NRx has positioned itself to potentially capture first-mover advantage in what has been an underserved market despite the enormous public health impact of suicide.
- This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of the addressable population compared to the Designation granted in 2017 for bipolar depression alone
- The Designation includes an FDA determination that NRX-100 has the potential to address an unmet need, based on FDA's assessment of the data submitted
- Determination of "unmet need" is a requirement for a Commissioner's National Priority Voucher (CNPV) program.
- Suicide is a public health crisis. Approximately 13 million adults seriously consider suicide each year, according to the CDC, 3.7 million make a plan to commit suicide. An American dies from suicide every 11 minutes. Active-duty personnel, veterans, and first responders have a four-fold higher risk of suicide.
In granting the Fast Track designation, FDA made the determination that NRX-100 has the potential to address an unmet medical need, based on an assessment of the preliminary data contained in the Fast Track designation request. This determination of unmet medical need aligns with the eligibility requirements for the Commissioner's National Priority Voucher Program (CNPV)i and for the FDA's Accelerated Approval Program.ii The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100.
Several well-controlled trials submitted to FDA in support of Fast Track Designation demonstrated a clinically meaningful and statistically significant reduction of suicidal ideation. In a
"We thank FDA for its thoughtful review of our Fast Track designation request, and believe this regulatory determination is a significant step forward in our goal to address the national crisis of suicide among soldiers, first responders, veterans, and civilians alike." said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals. "Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine. This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT. We look forward to working closely with the FDA in our quest to Bring Hope to Life."
Under the terms of the Fast Track program, NRx will be posting an expanded access policy for NRX-100 in the next two weeks and seeking a meeting with FDA leadership to finalize the data to be submitted under the Accelerated Approval / CNPV application. In addition to the benefits above, Fast Track Designation also grants enhanced communication with the FDA, as well as potential Priority Review and Rolling Review.
NRX-100 in Suicidal Ideation in Patients with Depression, Including Bipolar Depression
According to the CDC, approximately 13 million adults seriously consider suicide each year, 1.5 million attempt suicide, and an American dies from suicide every 11 minutes. NRX-100 – IV ketamine for suicidality in patients with depression, including bipolar depression – is designed to help address this national crisis.
NRx will be submitting patient-level 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 currently only approved by FDA only for use as an anesthetic and, therefore, not reimbursed by most insurance carriers for treatment of suicidality or depression. Intravenous ketamine is reimbursed by the Department of Veterans Affairs and the Department of Defense for its beneficiaries. By applying for FDA labeling for NRX-100 to treat suicidal depression, 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 has previously filed full Chemical Manufacturing and Controls (CMC) information for NRX-100 with FDA and has reported stability and sterility data sufficient to anticipate three-year room temperature shelf life for preservative-free ketamine. Having completed this Fast Track Designation, NRx is now filing draft labeling for NRX-100 to comply with the CNPV requirement.
NRX-100 is the first preservative-free presentation of ketamine to be filed with FDA. Currently available product, primarily of foreign manufacture, contains a known toxic preservative, Benzethonium Chloride (BZT) that is not Generally Recognized as Safe (GRAS) and is not allowed by FDA to be used in hand cleaners and topical antiseptics. NRx demonstrated long term stability and sterility with its patented preservative-free formulation of NRX-100. The Company has additionally filed a Citizen Petition seeking to have BZT removed from all intravenous ketamine products. The Company has instituted US-based high-volume manufacture of sterile, preservative-free ketamine.
Regarding Fast Track designation, FDA's website states:
A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
NRX-100 is poised to address the >
References
i https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
ii https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accelerated-approval-expedited-program-serious-conditions
iii Grunebaum, et al. Ketamine for rapid reduction of suicidal thoughts… Am J Psychiatry 2018;175:327-335.
iv Abbar, et al. Ketamine for the acute treatment of severe suicidal ideation… BMJ 2021;167:194-203
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 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 filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for 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 the Government of
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FAQ
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