The US Food and Drug Administration has approved esketamine, a drug derived from ketamine, as the first antidepressant that is not a variation of Prozac. Esketamine, which will be marketed as Spravato, was formally approved by the FDA late yesterday (March 5th) and will be released by Janssen Pharmaceuticals, a branch of Johnson & Johnson, as a nasal spray.
The drug is a major breakthrough in depression treatment partly because it’s extremely fast-acting: It can be effective within hours, whereas other antidepressants on the market take weeks to show results. Prozac, which acts by adjusting levels of serotonin in the brain, went on the market just over 30 years ago. All antidepressants approved since use the same mechanism of treating depression by adjusting serotonin levels. Esketamine instead blocks the receptor for a chemical called glutamate and so alters levels of glutamate in the brain. The drug has been approved for those with treatment-resistant depression, who’ve tried two antidepressants and not recovered sufficiently, and it will be taken alongside an oral antidepressant.
Though esketamine marks a new treatment for depression, several health professionals have voiced concerns about its effectiveness. Historically, the FDA has only approved drugs if they showed statistically significant results in two short-term trials; the esketamine trials, which were paid for by Janssen, did not achieve this. Instead, just one of two-month-long studies showed that those on esketamine had better results than those on a placebo. The FDA also considered a longer-term study, funded by Janssen, which showed that those who had benefited from esketamine treatment took a statistically longer time to relapse. The drug’s occasional side effects include suicidal thinking and potential for abuse.
Patients who are prescribed Esketamine nasal spray will be required to take it at certified clinics under doctors’ supervision, to limit the serious consequences of its potential side effects, and will be monitored for at least two hours after receiving treatment. They will typically be prescribed to take it twice a week for four weeks, and the wholesale acquisition cost of a such a treatment plan is $4,720 to $6,785, according to Stat News. A portion of those costs will be covered by insurance. Johnson & Johnson’s share price rose Wednesday morning (March 6th) following the news, though fell back to yesterday’s price by late morning.
Though this is the first time a ketamine-derived drug has been approved for use as an antidepressant, ketamine itself has been used that way for several years. The drug, which was first developed as an anesthetic in 1962, has long been approved by the FDA for use in surgeries, where it’s used as an anesthetic and to induce loss of consciousness. This means that it’s legal, though tightly regulated and not covered by insurance, to use ketamine in an “off label” way as a depression treatment. The first US ketamine clinics opened five years ago, and mean that patients in dire need of a new depressing treatment have been able to take ketamine in doctors’ clinics, though the high costs of this treatment has not been covered by insurance.
Ketamine was co-opted as a party drug, often known as “Special K,” soon after it was first released decades ago. Though its current use as an antidepressant is certainly groundbreaking, the World Health Organization has recognized ketamine as an essential medication since 1985, the New York Times reports. And so, while Ketamine is certainly well-known for its recreational use, this is not the case of a party drug-turned-medicine. Rather, it’s the story of a medication that became a party drug, and is now being recognized for entirely new medicinal properties.