The newly approved esketamine nasal spray will be administered under a doctor’s supervision at approved and certified treatment centers.
Clearing the way for the first major change to depression treatment in decades, the FDA approved a ketamine-derived nasal spray that can be used to rapidly treat depression on Tuesday (March 5).
“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” Dr. Erik Turner, who teaches psychiatry at Oregon Health & Science University, told The New York Times.
In recent years ketamine has garnered a lot of attention from the medical community because it quickly and effectively relieves depression and suicidal ideation. Ketamine treatments have become popular, but until now the drug, which is approved as an anesthetic, has been used off label. This means treatments are unregulated and not covered by insurance.
The medication approved this week is esketamine, which contains a part of the ketamine molecule. It was developed by Janssen Pharmaceuticals and will be sold under the name Spravato.
Since up to a quarter of depression patients don’t get relief from current antidepressants, people in the mental health community are happy to see a new option for treatment. However, Turner and others are cautious in their excitement.
“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,” Turner said.
Under the FDA recommendations, esketamine will be used in conjunction with an established antidepressants. Patients will get treatment twice a week for four weeks, and then as needed.
Although the nasal spray is non-invasive, it must be administered in a doctor’s office where patients can be observed for two hours. The use of esketamine could give patients fast relief from their symptoms, which is important since traditional antidepressants can take weeks to become effective.
Dr. Todd Gould, a psychiatrist at the University of Maryland School of Medicine who has done ketamine research, said that the potential for fast-acting relief is appealing, even if ketamine doesn’t completely revolutionize depression treatment.
“These are exciting times, for sure,” he said. “We have drugs that work rapidly to treat a very severe illness.”
Vanderbilt University professor Steven Hollon agreed.
“We’ve had nothing new in 30 years, so if this drug is an effective way to get a more rapid response in people who are treatment resistant, and we can use it safely, then it could be a godsend.”
The FDA fast-tracked esketamine’s approval process. Although the drug has been used safely as an anesthetic for decades, medical professionals will be carefully monitoring its use in the mental health space, researcher James Stone told Newsweek last year.
“Although ketamine is potentially a huge breakthrough in the treatment of depression, we still don’t know about the long-term safety, or about how to keep people well from depression without requiring regular ketamine dosing. Further studies are needed to address these questions.”