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NeuroRx’s sequential therapy posts encouraging preliminary data
October 2018
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WILMINGTON, Del.—September saw NeuroRx share initial top-line data from its Phase 2 STABIL-B trial of NRX-101 in patients with severe bipolar depression with acute suicidal ideation and behavior. Twenty patients were enrolled in the study, which is assessing sequential therapy of NRX-100 (ketamine) followed by NRX-101 as compared to lurasidone alone. The data was analyzed for maintenance of remission of depressive and suicidal symptoms and prevention of relapse, and although the study was not powered for efficacy, statistically significant differences were seen between the treatment groups. In addition, the therapy was well tolerated with no serious adverse events or discontinuations. NeuroRx has therefore launched a Phase 2b/3 pivotal study in the same indication under a Special Protocol Agreement (SPA) with the FDA, which granted NeuroRx Fast Track Designation for this sequential therapy last year. NeuroRx received the SPA and a Biomarker Letter of Support from the FDA for NRX-101 this year.

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