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FDA Panel Backs Ketamine-like Drug for Depression
An expert panel for the U.S. Food and Drug Administration has endorsed a drug for major depressive disorder that is a close relative to the club drug ketamine, or “Special K.”
Ketamine is a powerful anesthetic used in hospitals, though recent research has shown it may help those whose depression resists treatment.
If approved by the FDA, the new drug known as esketamine would be available to patients who haven’t found relief with at least two other antidepressants. The Tuesday vote was 14-2, with one member abstaining, according to CNN.
The FDA does not have to follow the recommendations of its expert panels, but it typically does. A decision is expected in early March.
Made by Janssen, a division of Johnson & Johnson, esketamine is a nasal spray medication that targets different pathways in the brain than other antidepressants do. Unlike antidepressants that can take four to six weeks to take effect, esketamine’s benefits can be felt within hours or days, the FDA said. That makes it likely that esketamine might be used effectively in conjunction with an antidepressant, the agency added.
Depression can be tricky to treat, with between 30 and 40 percent of those with major depressive disorder not having success with first-line antidepressants, the agency added.
Despite the panel’s approval, two of five key studies of esketamine failed to meet their primary goals. When taking esketamine, some patients experienced sedation, blood pressure spikes and dissociation (feeling disconnected from surroundings) within two hours of taking the drug, CNN reported.
Six patients died while taking esketamine in those trials, including three suicides, but agency documents concluded “it is difficult to consider these deaths as drug-related.”
Because of those caveats, patients will not be allowed to pick it up at a local pharmacy; instead a health care professional would have to monitor the person during the first two hours, the news service said.
Posted: February 2019
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