NRX Pharmaceuticals Inc (NRXP)

[Bob1968]

NRX Pharmaceuticals Announces Data Sharing Agreement Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Bipolar Depression
September 15 2023 - 06:46AM
PR Newswire (US)

Ketamine, an NMDA blocker, was highly effective in Bipolar subgroup (p<0.001)
NRx plans to present the data to FDA with a goal of identifying a path to an NDA
RADNOR, Pa., Sept. 15, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it has signed a data sharing agreement with the study leadership of a randomized, placebo-controlled trial of 156 patients hospitalized for Acute Suicidality and Depression in 7 French Government Hospitals.

This trial, conducted under International Good Clinical Practices and Helsinki standards demonstrated a dramatic and statistically-significant reduction in suicidal ideation and depression (P<.0001) among patients randomized to intravenous racemic ketamine, compared to those randomized to placebo. The trial reached its primary endpoint for all patients and demonstrated the largest effect among the subgroup with bipolar depression (84% vs 28% remission, drug vs. placebo; p<0.0001; Odds ratio 14).

The top line data from this trial were published in the British Medical Journal (BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194) and additional data reports are planned. The efficacy demonstrated confirms earlier, smaller trials conducted in the United States and elsewhere.

As disclosed previously, NRx met with the FDA in January 2023 at which time the FDA requested randomized, placebo-controlled data in support of intravenous ketamine for acute suicidality in the inpatient setting. Such trials are extraordinarily complex to organize and generally require Government support. In this case, NRx approached the Fondation FundaMental, led by Prof. Marion Leboyer, MD, PhD, who served on the NRx Scientific Advisory Board and facilitated establishing the current Data Sharing Agreement.

Under this agreement, NRx has translated the clinical study report, which will be submitted to FDA and is converting the electronic, patient level data files to a form suitable for FDA review. NRx plans to meet with FDA in the coming months to discuss a regulatory path for the use of ketamine to treat patients with Bipolar Depression and Acute Suicidal Ideation and Behavior.

"We at NRx are honored that the study leadership has agreed to share these landmark data so that they may be submitted to and reviewed by the US FDA," said Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals. "We look forward to a fruitful ongoing collaboration with Prof. Abbar and his study team leadership for the benefit of patients everywhere."