Suicidal bipolar depression accounts for 40% of people who try to harm themselves, yet there’s never been an FDA-approved drug for this indication.
Every second of every day, someone in the world attempts suicide.
NRx Pharmaceuticals is developing a drug for people whose suicidal thoughts stem from bipolar depression, the low mood phase associated with the severe mood swings of bipolar disorder.
If the clinical trials proceed as planned, the company hopes to commercialize the drug in 2024.
“Although bipolar depression accounts for only about 10 percent of all people who have depression, it accounts for about 40 percent of those who try to harm themselves,” says Dr. Jonathan Javitt, founder and chief scientist of NRx, the Nasdaq-listed company that merged with NeuroRx in 2021.
“Suicidal bipolar depression is a devastating disease and one that has not been addressed by pharmaceutical companies. There are no FDA-approved medicines today for people with suicidal bipolar depression.”
NRx’s multi-patented NRX-101 (Cyclurad) combines two FDA-approved pharmaceuticals: the tuberculosis drug D-cycloserine and the anti-infective drug lurasidone. It is meant to be taken orally at home.
Most conventional antidepressant drugs – which can actually increase risk of suicide — target the brain’s serotonin pathway. NRX-101 acts on the brain’s NMDA receptor, a newly validated target for treating suicidal ideation and depressive symptoms, particularly in bipolar depression.
A trial conducted at Herzog Hospital in Jerusalem showed a significant benefit of D-cycloserine (compared to placebo) in patients with treatment-resistant depression. And the effect of D-cycloserine in reducing suicidality was demonstrated in an independent trial in 2019.
