RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) disclosed encouraging preliminary outcomes from a study on NRX-101, an investigational drug designated as a breakthrough therapy. The drug demonstrated a promising, albeit not statistically significant, reduction in suicidality and symptoms of akathisia—a severe side effect of antidepressants linked to increased suicide risk—in patients with bipolar depression.
NRX-101, a combination of D-cycloserine (DCS) and lurasidone, was evaluated against lurasidone alone, the current standard care, due to ethical considerations preventing the use of a placebo group in such high-risk patients. Prior results from the company’s STABIL-B trial highlighted NRX-101’s effectiveness in reducing symptoms of depression and suicidality post-ketamine treatment. This latest study aimed to further assess the drug’s impact without prior ketamine use, with findings pointing to a comparable influence on depression when pitted against lurasidone.
Prof. Jonathan Javitt, Chairman and Chief Scientist at NRx Pharmaceuticals, remarked on the potential of NRX-101 to significantly alter the treatment landscape for bipolar depression, noting its capacity as the first oral antidepressant that could lower suicide potential—a stark contrast to existing antidepressants which are known to escalate suicide risk. Echoing the urgency of this development, Javitt underscored the dire statistics surrounding bipolar depression, including a 50% lifetime risk of suicide attempts among patients.
Dr. Philip Lavin, the study’s lead methodologist, emphasized the consistency of these results with the initial objectives of Phase 2 trials and the innovative “promising zone methodology” employed. Despite initial concerns from FDA leadership about the feasibility of demonstrating a clear difference in suicidality, these findings suggest that NRX-101 could show a notable advantage over current treatments in future, larger-scale registration trials.
The discovery sheds light on the critical need for new drugs that address the high risk of suicide and side effects like akathisia in bipolar depression, potentially offering a lifeline to patients whose only other approved treatment option has been electroshock therapy. With plans for further clinical validation, NRX-101 stands on the brink of becoming a “paradigm-changing blockbuster drug,” promising a new era of hope for individuals battling the severe impacts of bipolar depression.
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