WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said it has received written confirmation from the U.S. Food and Drug Administration supporting a path toward approval of its depression treatment NRX-100 without requiring additional clinical trials.
The company said the confirmation followed an in-person Type C meeting with officials from the FDA’s Division of Psychiatry Products, Office of Neuroscience, and Center for Drug Evaluation and Research.
According to NRx, the FDA indicated it is willing to review existing clinical trial data as primary evidence of effectiveness, along with real-world evidence from Osmind, Inc. as supporting data.
The company said no additional clinical trials, nonclinical studies, or formulation bridging studies were requested as part of the review process.
NRx said it plans to submit a New Drug Application for NRX-100, a preservative-free ketamine formulation, by June 2026.
The proposed indication has been expanded to include treatment of patients with severe depression, including those with suicidal ideation, rather than limiting use to patients with suicidality alone.
In materials discussed with the FDA, the company said ketamine showed improvement compared to placebo and active placebo, as well as comparable results to electroshock therapy, which it noted carries a reported risk of memory loss.
The FDA also indicated it would consider real-world evidence as confirmatory support for the drug’s effectiveness, according to the company.
“We deeply appreciate the FDA’s supportive meeting with us at the leadership level and guiding us to pursue a New Drug Application for NRX-100,” said CEO Jonathan Javitt.
NRx also has a separate Abbreviated New Drug Application under review for the use of preservative-free ketamine in anesthesia, which the company said has a target decision date in summer 2026.
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