The Food and Drug Administration approved a novel antidepressant — the first in decades to work in a completely new way in the brain — for people with depression that does not respond to other treatments.
The drug, a nasal spray called esketamine, has been eagerly anticipated by psychiatrists and patient groups as a powerful new tool to fight intractable depression. The spray acts within hours, rather than weeks or months as is typical for current antidepressants, and could offer a lifeline to about 5 million people in the United States with major depressive disorder who haven't been helped by current treatments, which accounts for about one in three people with depression.
Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai Health System in New York, did extensive early work to show ketamine was an effective treatment for depression. In 2000, he and other researchers published the first study showing that intravenous ketamine rapidly relieved depression.
Then, two years ago, he began receiving ketamine as part of a clinical trial. The first three treatments had no effect, but the fourth"was like a goddamn miracle, like someone just turned the light switch on," Wurst said."It was like the weight in my head, the cloud that was there for decades, just disappeared. It changed the entire course of my life."
The company opted for a nasal spray after concluding that IV administration was impractical and a pill wouldn't get enough of the drug to the brain, according to David Hough, the esketamine team leader at Janssen Research & Development, which is part of Johnson & Johnson. Despite the fact that ketamine can have euphoric effects, Hoffer said he is not very concerned about abuse of the new drug because of safety measures that will be put in place. Unlike a prescription that can be taken home and might be diverted into recreational use, esketamine will be administered under supervision in a health center.
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