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The Food and Drug Administration approved a novel antidepressant for people with depression that do not respond to other treatments — the first in decades to work in a completely new way in the brain.

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. That accounts for about 1 in 3 people with depression.

“This is undeniably a major advance.”

Jeffrey Lieberman

Columbia University psychiatrist

The medicine has a complex legacy because it is a component of ketamine, which was approved years ago as an anesthetic and was once popular as a party drug called Special K. Esketamine must be administered under medical supervision and can only be used in a certified doctor’s office or clinic, according to the conditions of the FDA approval. It is to be taken with an oral antidepressant.

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. In 2000, he and other researchers published the first study showing that intravenous ketamine rapidly relieved depression. After giving IV ketamine to seven patients, “to our surprise, they started saying within a few hours that they felt better,” Charney said. “It was a wonderful shock.”

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Washington Post: In biggest advance for depression in years, FDA approves novel treatment for hardest cases

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