NRx Pharmaceuticals: Last patient, last visit in Phase 2b/3 trial of NRX-101

NRx Pharmaceuticals announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the company’s patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program. Top-line results are expected around the end of this quarter. Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported. Positive data and FDA comment would trigger the next $4M milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329M in milestone payments and a royalty on net sales in the mid-teens