WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said it received guidance from the U.S. Food and Drug Administration that could allow the company to file a New Drug Application for NRX-100 under its existing Fast Track designation, based on clinical trial data and real-world evidence.
The company said it held an in-person Type C meeting at FDA headquarters with leadership from the Division of Psychiatry Products and the Center for Drug Evaluation and Research, along with its collaborator, Osmind Inc.
According to NRx, FDA officials provided oral guidance indicating that an application for NRX-100, a preservative-free formulation of ketamine, could be supported by existing data from adequate and well-controlled trials combined with confirmatory evidence from more than 65,000 patients identified in a real-world evidence dataset.
NRx said it plans to seek a broader proposed indication for treatment-resistant depression in patients who may have suicidality, rather than limiting the application to a narrower subset of patients with suicidality.
The company said it will work with the FDA to finalize a statistical analysis protocol for the real-world evidence dataset under recently published agency guidance.
In preliminary comments before the meeting, the FDA advised that no additional nonclinical studies would be required for review of the New Drug Application and that no bridging studies would be needed to support the preservative-free formulation compared with preservative-containing ketamine, according to NRx.
“We deeply appreciate the FDA’s meeting with us at the leadership level and guiding us to pursue a New Drug Application for NRX-100 for the benefit of the millions of Americans who tragically form a plan to end their lives each year,” said Dr. Jonathan Javitt, founder, chairman and chief executive officer of NRx Pharmaceuticals. He said the company intends to rely on existing clinical trial data and proposed real-world data from Osmind to apply for approval.
NRx said additional details will be provided after receipt of the FDA’s final meeting minutes.
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