NRx Pharmaceuticals, Inc. and Nephron Pharmaceuticals, Inc. 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.