NRX100/101

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

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (SBD-ASIB)
NRX-100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression
cyclurad_test_1 test_2 test_3 test_4

Clinical Data

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: