FDA Approves New Drug for Depression Called Esketamine; Chemical Cousin to Illegal Club Drug “Special K”, Otherwise Known as Ketamine
NEW YORK – The Food and Drug Administration (FDA) approved esketamine nasal spray Tuesday to treat people with depression who have not found relief with traditional antidepressants.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione of the FDA’s Center for Drug Evaluation and Research said in a statement.
The drug will be manufactured by Janssen, a subsidiary of Johnson & Johnson, and sold as Spravato, reported BBC. Janssen said the spray can help adults dealing with depression and suicidal thoughts within 24 hours. The drug works by targeting glutamate, a chemical that is essential for normal brain function.
Patients cannot administer the spray at home. They must be supervised at a doctor’s office or clinic for two hours every time they take Spravato because of its side effects including dissociation, suicidal thoughts and a sense of detachment from one’s identity, according to the FDA.
Spravato is intended to be taken alongside an oral antidepressant, reported BBC.
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The esketamine nasal spray’s wholesale price per treatment will be between $590 and $885, Johnson & Johnson said according to NPR. Jennifer Taubert, worldwide chairwoman of pharmaceuticals for Johnson & Johnson, was one of seven pharmaceutical company executives who testified at a Senate Finance Committee hearing on drug prices on Feb. 26.
Some experts maintain esketamine is not ready to hit the market.
“The threshold has been two adequate and well-controlled trials. In this case, they only got one,” Dr. Erick Turner, a former FDA reviewer and professor at Oregon Health and Science University, said according to BBC.
An FDA advisory panel made waves when it approved esketamine for depression in February.