NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, (NRx), a clinical-stage biopharmaceutical company and Nephron Pharmaceuticals, Inc. (Nephron), a leading manufacturer of sterile injectable drugs today announced the signing of a development and manufacturing agreement to manufacture a presentation of ketamine suitable for treating suicidal depression, an urgent public health need. Recent CDC data suggest that more than 3 million Americans have active thoughts of suicide and more than 50,000 die from suicide each year.
Ketamine has increasingly been recognized as valuable for rapid reduction of suicidal thoughts as part of a comprehensive program of care and its use in depression has been endorsed as standard of care by both the US Department of Defense and the Veterans Administration. However, no manufactured presentation of ketamine with been submitted to or approved by the US FDA for this purpose and caregivers rely on ad hoc compounding of ketamine, a practice that has been the topic of recent FDA warnings.
Submission of a New Drug Application for ketamine depends upon both the availability of data demonstrating safety and efficacy from well-controlled trials and upon the submission of data for a manufactured product demonstrating adherence to Good Manufacturing Practices and long term stability, among other requirements. These requirements are intended to be met via the NRx/Nephron partnership.
“We at NRx are excited to partner with Lou Kennedy and her team at Nephron and to avail ourselves of Nephron’s decades of manufacturing excellence in developing a lifesaving product that has the potential to be available for patients by the end of 2024.,” said Dr. Jonathan Javitt of Founder and Chief Scientist of NRx Pharmaceuticals. “We aim to combine Nephron’s history of producing highly-regarded FDA-inspected products with data from well-controlled clinical trials in seeking approval from FDA and regulators around the world.”
“There are few efforts as important as playing a role – through research and development – in tackling the nation’s mental health crisis,” said Lou Kennedy CEO and owner of Nephron Pharmaceuticals. “To this end, we are honored to partner with NRx Pharmaceuticals in a groundbreaking endeavor. Together, we are advancing the production of single-dose, intravenous Ketamine, which could be a crucial breakthrough for the treatment of depression. Not only are we addressing an immediate demand, but we are also laying the foundation for a potential New Drug Application, signifying a significant leap forward in the improvement of mental health outcomes for patients.”