Nrx pharmaceuticals (nasdaq:nrxp) announces promising findings in phase 2b/3 clinical trial of nrx-101 vs. lurasidone for treatment of suicidal bipolar depression
Nrx-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from akathisia relative to lurasidone - never previously shown with an oral antidepressant. suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (p=0.076) both nrx-101 and lurasidone, an accepted standard of care in bipolar depression, demonstrated approximately 50% reduction in symptoms of depression these data are comparable to previous statistically-significant finding of reduced suicidality and in the published stabil-b trial and support an approval pathway via a 300-person registrational trial with sustained remission in suicidality as the primary endpoint company believes that an oral antidepressant that demonstrates reduction in suicidality has potential to become standard of care for treatment of bipolar depression.
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