The U.S. Food and Drug Administration (FDA) on March 5 approved a form of ketamine to be prescribed for treatment-resistant depression. The drug, called esketamine, is administered as a nasal spray and is the first version of ketamine to be cleared to treat depression. It’s also the first new type of antidepressant drug since Prozac was released over 30 years ago. Many psychiatrists and pharmacists see the ruling as a win for desperate patients with few options, but others have raised concerns about the drug’s possibly serious side effects and have questioned its efficacy.
“On the whole, I think they made the right choice,” says Richard Friedman, a professor of psychiatry at Weill Cornell Medical College who was not involved in the decision. “This is a group of people who are really ill and for whom there are limited therapeutics. There’s no question ketamine has antidepressant efficacy, and it’s a new target.”
Esketamine will be sold under the brand name Spravato and is made by Janssen Pharmaceutical Company, a subsidiary of Johnson & Johnson. “Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research in a statement.
The FDA said that people who take the drug must be monitored by a health care provider for at least two hours after receiving it. Patients cannot take the spray home.
An estimated 30 to 40 percent of people with depression fail to respond to traditional antidepressant drugs like Prozac (a selective serotonin reuptake inhibitor or SSRI) and Cymbalta (a serotonin-norepinephrine reuptake inhibitor or SNRI), classifying them as “treatment resistant.” These patients have few alternative options, as all current antidepressants act on the same three neurochemicals: serotonin, dopamine, and norepinephrine. Ketamine, by contrast, acts on an entirely different pathway: the glutamate…