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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces Completion of Enrollment of its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
Exceeded originally target enrollment (70) with n=74 Last patient, last visit expected in approximately six weeks; data to follow shortly thereafterPositive
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Exceeded originally target enrollment (70) with n=74 Last patient, last visit expected in approximately six weeks; data to follow shortly thereafterPositive data triggers milestone payment from Alvogen, as previously announced.RADNOR, Pa., Jan. 22, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced completion of enrollment in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. Enrollment of 74 patients exceeded the original target of 70 patients, in order to enhance statistical power of the study. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.\n\n \n \n \n \n \n \n\n \n\"To our knowledge, NRX-101 is the first and only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it. On the basis of our previous trial, it was awarded Breakthrough Therapy Designation by the FDA and we aim to confirm its effect on depression and suicidal ideation in this trial. We thank our study investigators, dedicated trial sites, and of course, incredible patients,\" said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. \"We hope to bring a lifesaving home-use oral medicine to patients whose only currently-approved treatment is electroconvulsive therapy (ECT).\"\nThe Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) enrolled 74 patients with suicidal bipolar depression. This is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, ...