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
The Food and Drug Administration approved a novel antidepressant — the first in decades to work in a completely new way in the brain — for people with depression that does not respond to other treatments.
. Esketamine must be administered under medical supervision and can only be used in a certified doctor’s office or clinic, according to the conditions of the FDA approval. It is to be taken along with an oral antidepressant. That was the experience of Michael Wurst of Secaucus, New Jersey. Wurst, 37, has suffered from depression as far back as he can remember, but only began to seek therapy and medication in college. He had a negative experience with an oral antidepressant and stopped treatment. Later, when he decided to get therapy again, he was reluctant to try medication but eventually spent a decade cycling through various drugs and combinations, none of which helped.
“This offers hope, in capital letters,” said Charney, who is a co-inventor on a patent on the use of ketamine as a depression treatment that has been licensed by Johnson & Johnson. Esketamine, the drug Johnson & Johnson received approval to sell, will appear under the brand name Spravato. The FDA advisory committee voted 14-2 in February to recommend approval of the drug. That’s despite the fact that the evidence was more mixed than for other approved antidepressants, according to a report by agency staff. A memo said that typical antidepressants are approved on the basis of two positive short-term trials, but there was only one such trial for esketamine.
Hough said patients would receive the treatment two times a week for a month, then every week and then every other week, along with an oral antidepressant. Whether a patient stays on the drug for more than six months or a year will be up to the patient and his or her doctor, he said.
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