NRx Pharma Inks Development Agreement To Produce Ketamine

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm, has announced the signing of a development contract to produce a Ketamine formulation suited for intravenous administration in accordance with current FDA manufacturing rules. Existing Ketamine supplies are not labeled for the treatment of depression or suicidality, and they frequently fail to meet modern manufacturing regulations for single-dose injectable drugs. NRx and its manufacturing partner intend to provide further details 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 anaesthetic – 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, as per pharmabiz "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 Pharmaceuticals is a clinical-stage biopharmaceutical firm that is developing therapies for the treatment of central nervous system illnesses, including suicidal bipolar depression, chronic pain, and PTSD, using their NMDA platform.