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藥品發表股東更新信；更新重點強調了公司在美國臨床精神藥理學會年會上最近活動的潛在影響。
- 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.
- 美國臨床精神藥理學會（ASCP）於2024年6月會議主要關注使用靜脈注射****和鼻腔噴霧S-****作爲治療嚴重抑鬱和自殺傾向的新興標準。
- ASCP的3項開放標籤研究報告作者建議靜脈注射****與鼻腔噴霧S-****至少相當，可能具有優勢。
- NRx Pharmaceuticals現已達到其****配方（NRX-100）的9個月穩定點，並已啓動3個製造批次以用於未來藥物釋放。最近已經發布了NRX-100短期使用的非臨床安全性研究，並已提交給FDA。
- FDA領導在ASCP的公開評論中強調了肯定****的需要，以作爲****批准的限制條件，需要非臨床安全數據支持。
- 作爲已經獲得批准、調度3藥物的靜脈注射****在短期內的需要因最近的監管決定而增加，這可能會推遲更復雜的臨床試驗設計的調度1致幻藥物的途徑。
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).
賓夕法尼亞州雷德納，2024年6月10日 /美通社/ - 臨床階段生物製藥公司NRx Pharmaceuticals，Inc.（納斯達克：NRXP）（以下簡稱NRx Pharmaceuticals，該公司）今天宣佈在其網站NRx Shareholder Update上發佈了新的股東更新信，並進一步邀請有興趣的各方訂閱其電子郵件警報服務，以了解公司的進展情況：NRx Email Alerts。（注意：未來的新聞發佈中可能不會包含所有更新）。
譯文內容由第三人軟體翻譯。
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