“We’re … really the first company that organized around tackling suicidal depression,” Javitt says.
Dr. Jonathan Javitt, chairman and chief scientist of NRx
Suicide is one of the leading causes of death in the United States.
Suicide claimed the lives of 48,183 people in 2021, according to the Centers for Disease Control and Prevention. The agency estimates that 12.3 million American adults contemplated suicide in 2021, and 1.7 million people attempted suicide.
It’s hard to dispute that suicide is a serious public-health problem. Still, despite those alarming statistics, treatment options for suicidal behavior are limited. “Currently, there is only one FDA-approved medication for the prevention of suicidal behavior – clozapine – as well as a longstanding history of using lithium and electroconvulsive therapy,” Elizabeth Ballard explains in “Clinical Trials for Rapid Changes in Suicidal Ideation: Lessons from Ketamine.”
NRx Pharmaceuticals is on a mission to change that.
In an interview with Jane King from the NASDAQ MarketSite in Times Square, NRx Chief Scientist and founder Jonathan Javitt discusses the biotech company’s mission, pipeline and recent developments.
“We’re … really the first company that organized around tackling suicidal depression,” Javitt says.
The company’s efforts build on research conducted by his brother, Dan, showing that the NMDA (N-methyl-D-aspartate) receptor in the brain could hold the key to preventing suicidal behavior.
“A powerful NMDA antagonist such as ketamine can turn off thoughts of suicide within a couple of hours,” Javitt adds.
The problem with ketamine, Javitt explains, is that “it’s highly addictive, it’s neurotoxic and kills brain cells, and it can’t be given by mouth, so its magic for someone who has acute thoughts of suicide where the alternative is hospitalization [and] electroshock therapy, but as a chronic home-use drug, ketamine really has no role.”
With that in mind, the company is developing NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, to target the NMDA receptor in a way that’s “more like turning a dimmer instead of flipping a switch,” Javitt explains. NRX-101 is an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals on the development and marketing of NRX-101 for the treatment of suicidal bipolar depression.
NRx’s pipeline also includes NRX-100, which has received FDA Fast Track Designation as part of a protocol to treat patients with acute suicidality.
“So we’re on two different tracks: one where we expect FDA new-drug approval on ketamine [NRX-100] in the coming months, and one that’s slightly behind focused on NRX-101 for oral use,” Javitt says.
Watch the interview below: