RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced that the last patient in its Phase 2b/3 study of NRX-101 recently completed their day 42 visit. The company is now preparing to analyze the data from the trial. Positive results could trigger a milestone payment from pharmaceutical company Alvogen, who would then take on further development and commercialization costs for the program.
NRX-101, a patented combination of D-cycloserine, an NMDA antagonist, and lurasidone, is being tested for its potential use in treating suicidal bipolar depression. The drug has already been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA. It is the only oral medication that has shown a reduction in suicidal ideation in patients with bipolar depression.
“This is the first clinical trial, to our knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting,” said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. He further expressed his gratitude towards investigators, clinics, partners, patients and their families for their contribution to the trial.
The Phase 2b/3 trial was a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The primary aim was to measure the reduction in depression, while the secondary endpoint was the reduction of suicidal ideation. The trial demonstrated treatment compliance and concordance of local raters to central raters scores in excess of 94%, significantly higher than the industry standard typically seen in CNS trials.
The top-line results of the trial are anticipated to be released by the end of this quarter.
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