What to know about the first new antidepressant to be approved by the FDA in decades

The Food and Drug Administration has approved a new fast-acting drug for depression, and while it has given some people hope, the drug and its approval are not without controversy.

On March 5, the FDA approved the use of esketamine, a variant of the anesthetic ketamine, for use in a nasal spray sold under the name Spravato. Spravato isn’t intended for those who already have a depression medication that works well for them. Instead, it’s for the 12-20 percent of adults who struggle with treatment-resistant depression — patients who have already tried everything else to treat their depression.

The news of any new treatment option was a welcome one to both patients and doctors. The FDA approval means that insurers will start covering it, and because this is the first antidepressant the FDA has approved since 1987, this is in some ways “a milestone,” psychiatrist David Feifel told Popular Science.

Many doctors expressed cautious optimism, with a healthy dose of skepticism, about how patients might benefit from this treatment. The FDA’s approval process for Spravato wasn’t entirely conclusive, but an FDA panel voted to approve the drug regardless because they think the benefits of esketamine outweigh the risks.

The FDA held four clinical trials to test the effectiveness of Spravato. Three of the trials lasted four weeks. Two of these shorter trials did not demonstrate that the drug was effective, according to the FDA.

“Spravato nasal spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days,” the FDA’s announcement reads. “The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness.”

But the FDA knew patients with treatment-resistant depression were overdue for another treatment option. “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, acting director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

How Spravato Works

Spravato must be administered at a doctor’s office and cannot be used at home. After it’s administered, the patient must be monitored by their healthcare provider for at least two hours due to a risk of sedation, dissociation and other side effects — including dizziness, nausea, increased blood pressure, vominting and feeling drunk — associated with the drug.

Since patients will have to stick around for hours after receiving the medication, “It’s going to be an expensive treatment in terms of what’s required for health care providers,” Dr. Gerard Sanacora, a psychiatrist and the director of the Yale Depression Research Program, told Stat.

Ketamine Is Not A New Treatment For Depression

Researchers have been studying the possibility of using ketamine to treat depression since the 1990s — which is also when ketamine was a popular party drug called Special K. Johnson and Johnson, the makers of esketamine, built on years of research to create the drug, and doctors at some clinics were already offering ketamine as an out-of-pocket treatment to people with severe depression, according to the New York Times. Vox reported that more stories have been emerging of people trying ketamine as a way to get relief from their symptoms.

“This is potentially a game changer for millions of people,” Dr. Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York, told WBUR. “It offers a lot of hope.”

Amid the excitement, doctors pointed out that it’s still important to exercise caution. “This is an extraordinarily exciting time,” said Dr. Robert Meisner, a psychiatrist and the medical director of the Ketamine Service at McLean Hospital, told Stat. “That said, it’s important to proceed with enthusiastic caution.”