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NRx Pharmaceuticals announces DSMB recommendation to continue NRX-101 enrollment
The Fly

NRx Pharmaceuticals announces DSMB recommendation to continue NRX-101 enrollment

NRx Pharmaceuticals reported that the independent Data Safety Monitoring Board, or 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. 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. The 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. Based 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. The company expects 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 without prior use of ketamine. The company plans to discuss the path to approval in this population of people with Suicidal Treatment Resistant Bipolar Depression in the planned Comprehensive Breakthrough Therapy Meeting with FDA that is planned for the second quarter of 2023.

Published first on TheFly

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