Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant.
It will be prescribed by doctors for use in conjunction with an oral antidepressant for patients who have tried other forms of antidepressants that have not benefited from them.
Esketamine is derived from the sedative ketamine, which has been used for decades to prepare patients for surgery. The new drug is closely chemically related to the club drug ketamine. Ketamine was approved for use as an anesthetic in the 1970s.
That means about 5 million of the 16 million people in the US with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson.
In the short-term study, the spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days. That means patients who have not responded to "at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode", according to the FDA.
Unlike ketamine, psilocybin and MDMA have no legal medical use.
"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.
Spravato will cost between $590 and $885 per treatment.
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Spravato, which is administered via a nasal spray, is the first FDA-approved antidepressant in over 30 years.
Many doctors who have become comfortable offering ketamine for depression probably won't switch to esketamine, said Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation and a clinical associate professor at Albert Einstein College of Medicine.
The approval of the drug is the first major success since the arrival of a drug called Prozac that showed a ray of hope for fast-acting treatments in 1987.
The list price of a drug is not necessarily what patients actually pay.
But he hopes that doctors who are now using ketamine continue to do so.
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