USFDA approves Spravato, a controversial drug for depression

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment when measured with a psychiatric questionnaire.

Washington: A mind-altering medication related to the club drug Special K won US approval recently for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness.

The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anaesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

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The Food and Drug Administration approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.

There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. Those drugs target the feel-good brain chemical serotonin and can take weeks or months to kick in.

Ketamine and J&J’s version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.

When the drug works, its effect is almost immediate. That speed “is a huge thing because depressed patients are very disabled and suffer enormously,” said Dr John Mann, a psychiatrist and researcher at Columbia University. If the drug doesn’t work, physicians can quickly switch to other options, he noted.

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The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment when measured with a psychiatric questionnaire.

The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.