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NRx Pharmaceuticals Announces Positive Recommendation to Continue Enrollment in the Ongoing Trial of NRX-101 in Patients with Suicidal Treatment-Resistant Bipolar Depression
· The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned · No safety or futility signals were reported in the
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"· The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned\n· No safety or futility signals were reported in the first 50 patients\n· This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA\n· Trial has been upgraded to a Phase 2b/3 study that may be used for a registrational filing\nRADNOR, Pa., March 27, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage CNS biopharmaceutical company, today reported that the independent Data Safety Monitoring Board (DSMB) reviewed the safety and efficacy findings of the first fifty enrolled participants in the Company's clinical trial of NRX-101 for the treatment of Severe Bipolar Depression and Subacute Suicidal Ideation or Behavior (www.clinicaltrials.gov NCT NCT03395392). NRX-101 is a proprietary fixed dose combination of D-cycloserine and lurasidone. The people enrolled in this trial had bipolar depression and suicidal thoughts. They were being treated in the outpatient setting. Going forward, NRx will use the term \"Suicidal Treatment-Resistant Bipolar Depression\" to describe this potential indication.\n\n \n \n \n \n \n \n\n \nThe DSMB found no futility signal at this stage of the trial. Similarly, no safety signals were identified in association with NRX-101 and the DSMB recommended that enrollment in the trial continue as planned. According to the study's statistical analysis plan, the failure to identify futility requires that a numerical advantage of the investigational drug relative to the comparator treatment must be observed by the DSMB. The DSMB will continue to monitor safety and efficacy in the trial.\nBased on the DSMB findings, together with the recent completion of Phase 3/ anticipated commercial stage manufacture of NRX-101, the Company has upgraded the ongoing trial to a phase 2b/3 trial whose results may be used in a future registrational filing, should the primary endpoint be met. We expect top-line data from this trial in the fourth quarter of 2023. In the Type B meeting conducted with the FDA, the Company was guided to explore the use of NRX-101 in this broader population of patients who may benefit from NRX-101 w...