A drug similar to ketamine has been approved by the Food and Drug Administration (FDA) as a treatment for drug-resistant depression.
The New York Times reports that the drug will be marketed as a nasal spray to those who struggle with treatment-resistant depression. The drug, esketamine, is a chemical cousin to ketamine and will be marketed under the brand name Spravato, developed by the drug company Johnson and Johnson.
Spravato has been approved by the FDA for use among patients who have failed to respond to at least two traditional antidepressant medications, such as Prozac. It will only be available under medical supervision in treatment centers that are approved to administer the drug.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the FDA’s decision. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
Although ketamine is FDA approved only as a drug for anesthesia and is best known as the recreational drug Special K, there’s a substantial amount of research to suggest that it could also help alleviate treatment-resistant depression, or depression that does not respond to a standard course of treatment.
According to data from the National Institute of Mental Health (NIMH), nearly 16.2 million American adults have experienced a major depressive episode, or a little more than 6 percent of all Americans. Some estimates suggest that approximately one-third of these adults struggle with treatment-resistant depression (TRD), or depression that does not respond to traditional antidepressant medications.
There are a number of alternative methods that have been suggested to help alleviate treatment-resistant depression, from cognitive behavioral therapy (CBT) to transcranial magnetic stimulation (literally, magnets near your brain). Yet some clinical trials have indicated that ketamine could help alleviate symptoms of depression in as little as 2 hours, which has led some doctors to propose it as a short-term, fast-acting treatment method for those who are admitted to emergency rooms with suicidal ideation. There is also some evidence that ketamine could potentially be used to help treat other mental illnesses, such as posttraumatic stress disorder (PTSD).
In 2017, the use of ketamine in mental healthcare had a breakthrough when the American Psychiatric Association (APA) issued a set of guidelines for how psychiatrists could administer the drug safely and responsibly in a JAMA Psychiatry report. Although the report cautioned against the off-label use of the drug due to the “major gaps that remain in our knowledge about the longer-term efficacy and safety of ketamine infusions,” over the past few years a handful of wellness centers have nonetheless started offering high-priced ketamine injections.
Ketamine doesn’t come with risks: it can cause hallucinations, delirium and changes in perception, as well as nausea and agitation, as can esketamine in high doses. That’s why Spravato will contain a low dose of esketamine and will only be administered under the supervision of a doctor at an approved treatment center.