There are 16 million American adults who battle depression every day. As many as one fourth of them get little or no benefit from available treatments through drug or counseling. This segment of the population represent perhaps the greatest unmet need in psychiatry.
On Tuesday, the Food and Drug Administration approved a prescription treatment that may help them. It is a fast-acting drug derived from an old and widely used anesthetic, ketamine.
This move signals a shift from the Prozac era of antidepressant drugs. The newly approved treatment, called esketamine, is a nasal spray developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson. It will be marketed under the name Spravato. It contains an active portion of the ketamine molecule, whose antidepressant properties are not well understood yet.
“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.”
The generic anesthetic is already increasingly available for depression, at hundreds of clinics around the country that provide a course of intravenous treatments. Studies suggest it can help treatment-resistant people.
The cost for these treatments is usually out of pocket, as the generic anesthetic is not approved by the F.D.A. for depression. In contrast, esketamine most likely would be covered under many insurance plans, and its side effects are thought to be less dramatic.
For now, no one knows whether esketamine, or any of the other ketamine-based compounds being studied, are any more effective than the generic anesthetic itself — or, for that matter, whether the out-of-body and hallucinatory “side effects” are in fact integral to its antidepressant properties.
“For that, we will need head-to-head studies,” Dr. Zarate said. “And we don’t have those yet.”
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