Esketamine nasal spray, touted as biggest advance in years for treating depression, gets FDA approval

esketamine

The Food and Drug Administration approved a novel antidepressant late Tuesday [March 5] for people with depression that does 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 one in three people with depression.

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The label for the drug will carry a black box warning – the most serious safety warning issued by the FDA. It will caution users they could experience sedation and problems with attention, judgment and thinking, and that there’s potential for abuse and suicidal thoughts. …

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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.

Read full, original post: In biggest advance for depression in years, FDA approves novel treatment for hardest cases

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