Depression drugs are sorely in need of a breakthrough. The field hasn't seen a major advance since Prozac came on the market in the 1980s, and before that, the first antidepressants were developed in the 1950s. A well-known anesthetic called ketamine may be the revolutionary medicine that drug developers at Johnson & Johnson ($JNJ) are chasing to bring the next generation of depression drugs to patients.
The drug, often used illicitly in the club scene and known as "Special K," has caught the eye of J&J European subsidiary, which is investigating the drug's potential to treat depression in the form of a nasal spray. So far, the company has advanced the drug--a slightly altered version of ketamine called esketamine--to midstage clinical trials.
Academic researchers from DeBakey Veterans Affairs Medical Centre, Baylor College of Medicine in Houston, and the Icahn School of Medicine at Mount Sinai in New York tested the drug in 72 patients with hard-to-treat depression. The study yielded a 63.8% response rate, compared with 28% in the control arm. The response rate for ketamine fell to 45.7% after a week, but that was still significantly higher than the control arm. The study was published in August in the American Journal of Psychiatry.
Depression is difficult to treat in part because only some patients benefit from medications, and even then, they do so to varying degrees. Perhaps because of the desperate need for new antidepressants, ketamine is already gaining attention from some physicians. Doctors have started prescribing the drug off-label in low doses to patients for quick relief, according to Scientific American's Gary Stix.
The FDA, too, clearly recognizes the need for new therapies to combat depression, which affects an estimated one in 10 U.S. adults, according to CDC statistics. Esketamine has been bestowed with fast-track status by the FDA, and J&J neuroscience R&D head Husseini Manji has said he hopes to apply for the agency's new "Breakthrough Therapy" designation.
In the meantime, off-label prescribing could continue in the absence of better alternatives. And if J&J eventually comes up with a sellable drug, the company will have to deal with keeping it out of reach for people who want to use the drug recreationally--something J&J says it is already working on. But until an FDA blessing, patients and industry alike will be left speculating on ketamine's role in treating depression--if it has one at all.
- read more at Scientific American