NRx Pharmaceuticals, Inc. , a clinical-stage biopharmaceutical company, today announced US Food and Drug Administration (FDA) has granted

NRx Pharmaceuticals, Inc. ，一家临床阶段的生物制药公司，今天宣布美国食品和药物管理局（FDA）已授予

Fast Track

快速通道

designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. This designation for NRX-100 as a standalone drug is a 10-fold expansion of the addressable population for NRX-100, compared to the designation granted in 2017 for NRX-100 in combination with NRX-101 (DCS/lurasidone) for treatment of Suicidal Bipolar Depression..

将NRX-100指定用于治疗抑郁症患者的自杀意念，包括双相抑郁症。与2017年授予NRX-100与NRX-101（DCS/鲁拉西酮）联合使用的治疗双相抑郁自杀的指定相比，此次NRX-100作为单一药物的指定使其可治疗人群扩大了10倍。

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).

在授予快速通道资格时，FDA 根据对快速通道资格申请中包含的初步数据的评估，确定 NRX-100 有潜力满足未被满足的医疗需求。这一未满足医疗需求的认定符合专员国家优先券计划 (CNPV) 的资格要求。

and for the FDA's Accelerated Approval Program.

以及FDA的加速批准计划。

The Company has applied for a CNPV, which has the potential to substantially shorten the review cycle for NRX-100.

公司已申请了CNPV，这有可能大幅缩短NRX-100的审查周期。

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

提交给FDA以支持快速通道资格的几项良好对照试验显示，自杀意念在临床上有意义且统计学上显著减少。在一项

Columbia University

哥伦比亚大学

study licensed by NRx, suicidal patients treated with intravenous ketamine demonstrated a 55% response (i.e. 50% reduction in suicidality) compared to a 30% response to active comparator (P<.02).

由NRx授权的研究显示，接受静脉注射氯胺酮治疗的自杀患者反应率为55%（即自杀倾向减少50%），而与之对比的活性对照组反应率为30%（P<.02）。

In a trial sponsored by the Government of

在政府赞助的试验中

France

法国

and licensed by NRx, 63% of patients achieved full remission from suicidal ideation in three days compared to 31% of those who received placebo (P<.001). This effect has not been proven with intranasal administration of ketamine.

由NRx授权，63%的患者在三天内实现了自杀意念的完全缓解，而接受安慰剂的患者中这一比例为31%（P<.001）。这种效果尚未通过鼻内给药的氯胺酮得到证实。

'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.

“我们感谢FDA对我们快速通道指定请求的深思熟虑的审查，并相信这一监管决定是我们实现解决士兵、急救人员、退伍军人和普通民众中自杀这一全国性危机目标的重要一步。” 博士说道。

Jonathan Javitt

乔纳森·贾维特

, 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.

NRx制药公司董事长兼首席执行官表示：“大规模政府支持的试验表明，使用氯胺酮可以显著减少自杀意念和抑郁症状，且具有强大的统计学意义。该药物还被证明在治疗抑郁症方面不逊于电休克疗法，且没有ECT的负面副作用。”

We look forward to working closely with the FDA in our quest to Bring Hope to Life.'.

我们期待与FDA密切合作，以实现‘为生命带来希望’的目标。

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..

根据快速通道计划的条款，NRx将在未来两周内发布NRX-100的扩大使用政策，并寻求与FDA领导层会面，以最终确定加速批准/CNPV申请下提交的数据。除了上述好处外，快速通道指定还提供了与FDA的增强沟通，以及潜在的优先审查和滚动审查。

NRX-100 in Suicidal Ideation in Patients with Depression, Including Bipolar Depression

NRX-100在抑郁症患者，包括双相抑郁症患者的自杀意念中的应用

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..

根据CDC的数据，每年大约有1300万成年人认真考虑自杀，150万人尝试自杀，每11分钟就有一名美国人死于自杀。NRX-100——用于治疗抑郁症（包括双相抑郁症）患者的自杀倾向的静脉注射氯胺酮——旨在帮助应对这一全国性危机。

NRx will be submitting patient-level data from controlled clinical

NRx 将提交来自对照临床试验的患者层面数据

trials

试验

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.

这些研究证明，氯胺酮在治疗各种形式的抑郁症（包括有主动自杀意念的患者）方面，不仅优于安慰剂和活性对照药物，而且在与电休克疗法的对比中也表现出非劣效性或优越性。尽管氯胺酮的各种形式正越来越多地用于治疗抑郁症及相关疾病，但目前它仅被FDA批准作为麻醉剂使用，因此大多数保险公司不会为治疗自杀倾向或抑郁症报销费用。

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..

静脉注射氯胺酮已被退伍军人事务部和国防部批准报销，惠及受益人。通过申请NRX-100的FDA标签以治疗自杀性抑郁，该公司希望让所有美国人都能使用这种可能挽救生命的疗法，而不仅限于那些能够自费支付的人。

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..

公司此前已向 FDA 提交了 NRX-100 的完整化学制造与控制 (CMC) 信息，并报告了足够的稳定性及无菌数据，预计不含防腐剂的氯胺酮在室温下可拥有三年的有效期。在完成这一快速通道指定后，NRx 现在正为 NRX-100 提交草案标签，以符合 CNPV 要求。

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-100是首个向FDA提交的无防腐剂氯胺酮制剂。目前市面上的产品主要由外国制造，含有已知有毒的防腐剂苯扎氯铵（BZT），该物质未被普遍认为是安全的（GRAS），且FDA不允许其用于手部清洁剂和外用抗菌剂。

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..

NRx 通过其获得专利的无防腐剂 NRX-100 配方展示了长期稳定性和无菌性。该公司还提交了一份公民请愿书，要求将苯扎氯铵从所有静脉注射氯胺酮产品中去除。公司已在美国建立了无菌、无防腐剂氯胺酮的高产量生产。

Regarding Fast Track designation, FDA's website states:

关于快速通道指定，FDA的网站上说：

A drug that receives Fast Track designation is eligible for some or all of the following:

获得快速通道资格的药物有资格享受以下部分或全部权益：

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.

更频繁地与FDA开会，讨论药物的开发计划，并确保收集到支持药物批准所需的数据。

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

更频繁的FDA书面沟通，涉及拟议临床试验的设计和生物标志物的使用等内容

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

如果符合相关标准，则有资格获得加速批准和优先审查。

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..

滚动审评，这意味着制药公司可以提交其生物制品许可申请（BLA）或新药申请（NDA）的已完成部分供FDA审评，而不用等到NDA的每个部分都完成才能进行整体申请的审评。通常，在制药公司将完整申请提交给FDA之前，BLA或NDA的审评不会开始。

NRX-100 is poised to address the >

NRX-100 即将解决 >

$3

$3

billion Suicidal Depression market in the US.

美国数十亿的自杀性抑郁症市场。

References

参考文献

i

我

https://www.fda.gov/industry/

https://www.fda.gov/industry/

commissioners-national-priority-voucher-cnpv-pilot-program

专员国家优先券（CNPV）试点项目

ii

二

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

accelerated-approval-expedited-program-serious-conditions

加速批准快速计划严重病症

iii

iii

Grunebaum, et al. Ketamine for rapid reduction of suicidal thoughts… Am J Psychiatry 2018;175:327-335.

格鲁内鲍姆等。氯胺酮快速减少自杀念头……《美国精神病学杂志》2018；175：327-335。

iv

四

Abbar, et al. Ketamine for the acute treatment of severe suicidal ideation… BMJ 2021;167:194-203

阿巴拉等。氯胺酮用于严重自杀意念的急性治疗……BMJ 2021；167：194-203

About NRx Pharmaceuticals, Inc.

关于NRx Pharmaceuticals公司

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 Pharmaceuticals 是一家临床阶段的生物制药公司，基于其 NMDA 平台开发用于治疗中枢神经系统疾病的疗法，特别是自杀性抑郁、慢性疼痛和 PTSD。该公司正在开发 NRX-100（无防腐剂静脉注射氯胺酮）和 NRX-101（口服 D-环丝氨酸/鲁拉西酮）。

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-100 已获得治疗抑郁症（包括双相抑郁症）中自杀意念的快速通道资格。NRX-101 已获得治疗自杀性双相抑郁症的突破性疗法资格。

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 .

NRx 最近提交了一份简略新药申请（ANDA），并为 NRX-100（静脉注射氯胺酮）启动了新药申请，同时申请了专治自杀性抑郁的局长国家优先券计划。该申请基于在美国国立卫生研究院和政府支持下进行的良好对照临床试验结果。