FDA-compliant manufacture of intravenous Ketamine is a required component of a New Drug Application

符合FDA要求的静脉注射氯胺酮制造是新药申请的必要组成部分

Intravenous Ketamine has become widely used for treating depression and suicidality but has never been presented to FDA for approval

静脉注射氯胺酮已被广泛用于治疗抑郁症和自杀倾向，但从未提交FDA批准

Potential to file New Drug Application for Ketamine in 2024 based on existing clinical data and newly-developed, modern commercial manufacturing protocols

根据现有的临床数据和新开发的现代商业制造协议，在2024年为氯胺酮提交新药申请的潜力

Further information is anticipated to be released in an upcoming 8K securities filing

预计将在即将到来的8K证券提交中发布更多信息

RADNOR, Pa., Oct. 31, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ('NRx Pharmaceuticals', the 'Company'), a clinical-stage biopharmaceutical company today announced the signing of a development contract to manufacture a presentation of ketamine suitable for intravenous administration under current FDA manufacturing regulations.

RADNOR，Pa，2023年10月31日/PRNewswire/-NRx Pharmaceuticals，Inc。（纳斯达克股票代码：NRXP）（'NRx Pharmaceuticals'，'公司'），一家临床阶段生物制药公司今天宣布签署根据现行FDA制造法规制造适合静脉注射的氯胺酮的开发合同。

Existing supplies of Ketamine are not labeled for treatment of depression and suicidality and often do not conform to modern manufacturing requirements for single-dose injectable medications. NRx and its manufacturing partner plan to release further information in an upcoming 8K filing..

现有的氯胺酮供应没有标签用于治疗抑郁症和自杀倾向，并且通常不符合单剂量注射药物的现代制造要求。NRx及其制造合作伙伴计划在即将到来的8K归档中发布更多信息。。

As intravenous Ketamine becomes more widely used to treat depression and suicidality, the supply of Ketamine – which today is approved only for use as an anesthetic – becomes increasingly tenuous. Moreover, suppliers of Ketamine are increasingly challenged by FDA warnings to patients and healthcare providers about potential risks associated with compounded Ketamine products.1 Compounded products are distributed under state pharmacy laws by compounding pharmacies and may not comply with various aspects of the Food, Drug, and Cosmetics Act..

随着静脉注射氯胺酮越来越广泛地用于治疗抑郁症和自杀倾向，氯胺酮的供应-今天仅被批准用作麻醉剂-变得越来越脆弱。此外，氯胺酮供应商越来越受到FDA警告患者和医疗保健提供者与复合氯胺酮产品相关的潜在风险的挑战.1复合产品根据国家药房法律通过复合药房分发，可能不符合食品，药品的各个方面，和化妆品法。。

'We at NRx are excited to have identified a strong manufacturing partner for the development of what we anticipate will be a lifesaving product that has the potential to be available for patients by the end of 2024. We and our partner look forward to sharing further information as the manufacturing, regulatory, and business plans are finalized,' said Stephen Willard, JD, CEO of NRx Pharmaceuticals..

“NRx的我们很高兴能够找到一个强大的制造合作伙伴来开发我们预计将成为到2024年底有可能为患者提供的救生产品。NRx Pharmaceuticals首席执行官Stephen Willard博士说，随着制造，监管和业务计划的最终确定，我们和我们的合作伙伴期待分享更多信息。。

About NRx PharmaceuticalNRx 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's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor and is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression (S-TRBD), which includes patients with both acute and sub-acute suicidality, an indication for which the only approved treatment is electroshock therapy.

关于NRx PharmaceuticalNRx Pharmaceuticals是一家临床阶段的生物制药公司，根据其NMDA平台开发治疗中枢神经系统疾病，特别是自杀性双相抑郁症，慢性疼痛和创伤后应激障碍的治疗药物。该公司的牵头项目NRX-101是D-环丝氨酸和lurasidone的口服固定剂量组合，针对大脑的N-甲基-D-天冬氨酸（NMDA）受体，正在进行2b/3期自杀临床试验。治疗抵抗性双相抑郁症（s-TRBD），包括急性和亚急性自杀性患者，唯一批准的治疗方法是电击疗法的适应症。

The Company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD, to help bring NRX-101 to a global population of patients with unmet medical need. NRx Pharmaceuticals is currently exploring NRX-101's potential to act as a non-opioid chronic pain treatment option and has recently announced a renewed focus on the use of intravenous ketamine for treatment of acute suicidality..

该公司已与Alvogen Pharmaceuticals合作，Alvogen Pharmaceuticals拥有NRX-101治疗S-TRBD的全球权利，以帮助将NRX-101带入全球未满足医疗需求的患者群体。NRx Pharmaceuticals目前正在探索NRx-101作为非阿片类药物慢性疼痛治疗选择的潜力，并且最近宣布重新关注使用静脉注射氯胺酮治疗急性自杀。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示

This press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals.

本新闻稿包括1995年美国私人证券诉讼改革法案“安全港”规定含义内的“前瞻性声明”，其中可能包括但不限于有关我们的财务前景，产品开发，业务前景，市场和行业趋势和条件，以及公司的战略，计划，目标，和目标。

These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. Actual results could differ materially from those contemplated by the forward-looking statements.

这些前瞻性陈述基于公司管理层当前的信念，期望，估计，预测和预测，以及公司管理层目前所做的假设和信息。实际结果可能与前瞻性声明所预期的结果大不相同。

A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, as may be supplemented, or amended by the Company's Quarterly Reports on Form 10-Q.

本公司向证券交易委员会提交的文件（包括其表格10-K上的年度报告）中对这些因素和其他因素（包括公司的风险和不确定性）进行了讨论，可能会对此进行补充或修订。公司关于表格10-Q的季度报告。

Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements..

鉴于这些风险，不确定性和因素，警告您不要过分依赖这些前瞻性陈述，这些陈述全部由这些警示性陈述所限定。。

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above..

无论是由于新信息，未来事件还是其他原因，本公司均无义务修改任何前瞻性声明。因此，您不应依赖任何前瞻性声明，所有前瞻性声明均通过参考上述警示性声明进行限定。。

1 https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine

1 https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine

SOURCE NRx Pharma

SOURCE NRx Pharma