NRx Pharmaceuticals Publishes Shareholder Update Letter; Update Highlights Potential Implications Of The Company's Recent Activities At The Annual Meeting Of The American Society Of Clinical Psychopharmacology
NRx Pharmaceuticals Publishes Shareholder Update Letter; Update Highlights Potential Implications Of The Company's Recent Activities At The Annual Meeting Of The American Society Of Clinical Psychopharmacology
NRx药品发表股东更新信；更新重点强调了公司在美国临床精神药理学会年会上最近活动的潜在影响。
- The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) focused heavily on increasing use of intravenous ketamine and intranasal S-ketamine as the emerging standard of care for treating severe depression and suicidality
- Presenters from 3 open label studies at the ASCP suggested that intravenous ketamine is at least equivalent and may have advantages over intranasal S-ketamine
- NRx Pharmaceuticals has now reached the 9-month stability point with its ketamine formulation (NRX-100) and has initiated 3 manufacturing lots for future drug release. Nonclinical safety for short term use of NRX-100 has recently been published and submitted to FDA
- FDA leadership, in public comments at ASCP, focused on the need for nonclinical safety data for intravenous ketamine as a condition of ketamine approval
- The short-term need for intravenous ketamine as an already-approved, schedule 3 drug, is heightened by recent regulatory decisions that may delay the path of potent, schedule 1 psychedelic drugs that may require more complicated clinical trial designs.
- 美国临床精神药理学会（ASCP）于2024年6月会议主要关注使用静脉注射氯胺酮和鼻腔喷雾S-氯胺酮作为治疗严重抑郁和自杀倾向的新兴标准。
- ASCP的3项开放标签研究报告作者建议静脉注射氯胺酮与鼻腔喷雾S-氯胺酮至少相当，可能具有优势。
- NRx Pharmaceuticals现已达到其氯胺酮配方（NRX-100）的9个月稳定点，并已启动3个制造批次以用于未来药物释放。最近已经发布了NRX-100短期使用的非临床安全性研究，并已提交给FDA。
- FDA领导在ASCP的公开评论中强调了肯定氯胺酮的需要，以作为氯胺酮批准的限制条件，需要非临床安全数据支持。
- 作为已经获得批准、调度3药物的静脉注射氯胺酮在短期内的需要因最近的监管决定而增加，这可能会推迟更复杂的临床试验设计的调度1致幻药物的途径。
RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts . (Note: not all updates will be included in a Press Release in the future).
宾夕法尼亚州雷德纳，2024年6月10日 /美通社/ - 临床阶段生物制药公司NRx Pharmaceuticals，Inc.（纳斯达克：NRXP）（以下简称NRx Pharmaceuticals，该公司）今天宣布在其网站NRx Shareholder Update上发布了新的股东更新信，并进一步邀请有兴趣的各方订阅其电子邮件警报服务，以了解公司的进展情况：NRx Email Alerts。（注意：未来的新闻发布中可能不会包含所有更新）。