Business
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%
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"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 depressionThese 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.Data from this study expand the potential utility of NRx-101 to treat both patients with suicidal bipolar depression (who will require prior use of ketamine) and those without subacute suicidality (nearly 7 million patients in the US).RADNOR, Pa., April 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical stage pharmaceutical company today that its Breakthrough Therapy designated investigational drug NRX-101 vs lurasidone demonstrated a promising, though not yet statistically significant 33% reduction in suicidality together with a 70% reduction (P=.076) reduction in symptoms of akathisia – a side effect of antidepressants that is closely linked to suicide and considered a medical emergency. Because of the high-risk nature of these patients, a placebo group could not be employed, and NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone, was compared to lurasidone alone (the standard of care). In the Company's previously published STABIL-B trial (STABIL-B), NRX-101 was demonstrated to be superior to lurasidone in reducing both depression and suicidality after ketamine while showing a trend towards reducing akathisia (a side effect involving restlessness and agitation that is considered a warning sign of impending suicide). In this trial, without prior use of ketamine, NRX-101 and lurasid...