This Drug, An Alternative To Marijuana And Ketamine, Could Treat Suicidal Depression And PTSD

It's hard to forget the feeling that took over the world when Robin Williams committed suicide. To think that “someone that successful, that funny, that rich, who has entertained so many ... could be so low as to take his own life is incomprehensible,” Larry King said at the time, putting a lot of people's sentiment into words.

The thing is, what happened was actually not that hard to grasp. Robin Williams was sick. He suffered from a chemical imbalance in his brain. He was clinically depressed, which isn't a state of mind, but a serious medical condition that needs to be treated.

Roughly 1 million people die every year by suicide, according to World Health Organization data. Furthermore, the U.S. alone sees 22 veterans and soldiers take their own lives every day; this means that more soldiers die when they come back home than during active duty.

There is one company that has been working on a solution this problem. It’s called NeuroRx.

Meet NeuroRx

Over the past few years, NeuroRx has been developing what it hopes will be the first oral drug to treat suicidal bipolar depression. The therapy in question is comprised of a single dose of ketamine HCl (NRX-100), followed by six weeks of daily oral doses of D-cycloserine + lurasidone (NRX-101). The NRX 101-based therapy is expected to enter Phase 3 clinical trials shortly, taking into account that the FDA recently granted it Fast Track status.

“Tragically, 50,000 to 60,000 Americans die of suicide every year," NeuroRx CEO Jonathan Javitt told Benzinga in a recent conversation. "Even though only 10 percent of people with depression have bipolar depression, it’s those people who are most likely to harm themselves. In fact, 40 percent of deaths from suicide occur in people with bipolar depression."

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Nonetheless, he explained, most of the drugs in the market right now aren't indicated for bipolar depression. Even worse, all of the antidepressant drugs out there, originally developed by Pfizer Inc. PFE, Roche Holding Ltd. (ADR) RHHBY and GlaxoSmithKline plc (ADR) GSK, among others, have not only gone generic, but also carry “suicide warnings” on the label now, meaning they increase the patient’s risk of suicide, he added. This has led these pharma giants to leave the space completely — just to remain on the safe side of things, creating a sort of development void.

This is where NeuroRx has come in, to fill that hole using a patented small-molecule platform technology.

Is Ketamine A Problem Or A Solution?

Ketamine has been recognized as a very potent antidepressant, and has even developed as such by Johnson & Johnson JNJ. The thing is, ketamine is also neurotoxic (it kills brain cells), hallucinogenic, highly addictive, often leads to abuse, and can only be administered intravenously or through the nose.

“People recognize the need for a family of drug that would achieve some of the potential benefits of ketamine in a gentler, more controllable manner,” Javitt said. “What we’ve found at NeuroRx is that we can achieve some of the same benefits of ketamine through the oral use of our drug, NRX-101.”

When asked to explain in simple words what NRX-101 does, Javitt said, “The drug raises the level of certain chemicals in the brain [that] are associated with relief of depression and with ‘turning off’ ideas of suicide. This is associated with a chemical in the brain called GLX; it’s a neurotransmitter, so it basically sends thoughts from one neuron to another.”

If everything goes according to plan with the Phase 3 trial, the drug could hit the market by 2019, Javitt added.

The Numbers

Benzinga asked about the size of the addressable market for NeuroRx’s drug.

"The U.S. initial market is a group of 150,000 patients per year, who suffer from bipolar depression," Javitt said."We’ve also seen a potential to expand that market to PTSD and major depression. So, we think the family of drugs has the potential to benefit more than 20 million Americans." This represents a market in excess of $10 billion.

According to the CEO, NeuroRx is completely funded, but is still open to a raise some time soon, as well as the option of going public.

“We are interested in giving hope to a whole category of Americans, who until now have very few therapeutic options, most of them terrible, like electroshock,” the CEO said.

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