NRx Pharmaceuticals (NASDAQ: NRXP) announced completion of an in-person Type C guidance meeting with the U.S. Food and Drug Administration, attended by leadership from the Division of Psychiatry Products, Office of Neuroscience and Center for Drug Evaluation and Research. Based on oral guidance, the company believes it has a path to file a New Drug Application for NRX-100, a preservative-free ketamine formulation, supported by existing adequate and well-controlled trials and confirmatory evidence from more than 65,000 patients in a Real World Evidence dataset, while also seeking a broader indication for treatment-resistant depression with suicidality. The FDA advised that no additional nonclinical or bridging studies would be required, and the company said it will work with the agency to finalize a statistical analysis protocol, with further details to follow upon receipt of formal meeting minutes.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer