When you want to develop a drug for, say, cancer, objective measures such as survival rate can tell regulators just how effective it is compared to a standard drug or placebo. But in diseases involving the brain, scientists often have to settle for crude measures for assessing how patients perform or feel after treatment. And the wild card here is a placebo effect that can be very difficult to factor into studies and has been fingered for the death of multiple development programs.
Fresh from raising $80 million and being featured in The New York Times, Naurex has posted Phase IIb data to back up its belief it will be the company that finally turns the receptor affected by party drug Special K into a viable target for treatment of depression.
Whatever data Naurex collected from its recently completed Phase IIb study of an NMDA receptor drug for depression, it must have deeply impressed its investment syndicate. Today the company unveiled the news that it has rounded up an $80 million round designed to put the drug through a late-stage pivotal trial.
The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.
Researchers have identified 9 RNA blood markers that can be used as part of a panel to diagnose depression. They said it is the first blood test to diagnose adult depression.
A small molecule found in lower levels in the brains of people who are depressed may give scientists a better idea of how to treat patients with depression more effectively.
Evanston, IL's Naurex nailed down another $25 million in venture funding to accelerate its two-pronged depression program, posting positive midstage results for its top prospect.
Yet another research team has pulled off a small study demonstrating the enormous potential of ketamine as a treatment for depression, highlighting again how difficult it has been to push beyond evidence of a rapid-acting treatment to develop a therapy with durable effects.
The notion that a party drug could be repurposed into a "miracle" cure for severe, treatment-resistant depression is an almost irresistible story line in the popular press. And there's no reason why it can't be recycled using results from the same small, short-duration study design that long ago attracted some of the world's largest research organizations still engaged in researching new drugs in one of the most difficult fields in R&D.
Cambridge University researchers and colleagues have identified an elegantly simple biomarker for major clinical depression in teenage boys: high levels of the stress hormone cortisol combined with behavioral symptoms.