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NRx Pharmaceuticals Announces Signing of a Development Agreement for the Manufacture of Ketamine to Treat Suicidality and Depression
FDA-compliant manufacture of intravenous Ketamine is a required component of a New Drug ApplicationIntravenous Ketamine has become widely used for treating
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"FDA-compliant manufacture of intravenous Ketamine is a required component of a New Drug ApplicationIntravenous Ketamine has become widely used for treating depression and suicidality but has never been presented to FDA for approvalPotential to file New Drug Application for Ketamine in 2024 based on existing clinical data and newly-developed, modern commercial manufacturing protocols Further information is anticipated to be released in an upcoming 8K securities filingRADNOR, 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. 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.\n\n \n \n \n \n \n \n\n \nAs 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.\n\"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.\nAbout 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 pr...