NRx-101 NRx’s investigational medicine regimen NRX-101, if approved by the US FDA and other health-regulatory agencies, would be the first medicine regimen to treat suicidal bipolar depression. Today, no medicine is approved to treat patients with bipolar depression suffering suicidal ideation. The only FDA-approved treatment for this lethal condition is electroconvulsive therapy (ECT). With approximately fifty percent of patients with bipolar depression attempting suicide, new treatments are urgently needed.
NRX-101 is a patented, oral fixed-dose combination of two FDA-approved drugs: Dcycloserine, an NMDA receptor modulator; and Lurasidone, a 5-HT2a receptor antagonist. The FDA has granted the combination therapy a Breakthrough Therapy Designation (BTD) for the treatment of severe depression and acute suicidal ideation and behavior in patients with bipolar depression, after initial stabilization with ketamine or other effective therapy. BTD provides a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and for which preliminary clinical evidence indicates the medicine may demonstrate substantial improvement over available therapies.
NRx’s ongoing phase 3 trials of NRX-101 focus on patients in emergency care with active suicidal ideation and require an initial single dose of ketamine (NRX-100) to stabilize their condition. The trial is also studying patients being treated in the outpatient setting who have less acute suicidal ideation.
NRx Clinical Trial Information
Full results from NRx’s STABIL-B trial, a phase 2 study were presented at the American College of Neuropsychopharmacology in December 2019. The US Food and Drug Administration granted BTD to NRX-101 based on this study.
Further information about the STABIL-B trial can be found here,
https://ir.nrxpharma.com/news-events/press-releases/detail/46/neurorx-reportsphase-2-efficacy-for-nrx-101-a, and in the graph below: