RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently 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.
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.
“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.
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