Esketamine nasal spray can now be used as a stand-alone treatment for treatment-resistant depression in adults, according to the FDA. (Photo by Douglas Sasha via Getty Images)
For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug similar to ketamine as a stand-alone treatment for adults with treatment-resistant depression (TRD). The drug is only approved for use in a clinical setting under the supervision of a healthcare professional.
TRD is a severe form of major depressive disorder in which patients' symptoms are not relieved by standard antidepressant medications. Specifically, patients with TRD have not responded to at least two courses of antidepressants in the past. The condition is thought to affect about a third of adults with major depressive disorder, so there is an urgent need for new, effective treatments for TRD.
Esketamine, a molecular analogue of regular ketamine, was approved as a treatment for TRD in 2019, but it had to be taken with another traditional antidepressant. Now, the new FDA approval allows patients to use a ketamine-based nasal spray sold under the brand name Spravato without the need to add another antidepressant, according to a statement from the drug’s manufacturer, Janssen Pharmaceuticals, released Jan. 21.
But what is esketamine? And what will the new FDA approval mean in practice?
What is esketamine?
Esketamine is a “brother” of the anesthetic ketamine, as it is made up of the same basic molecules, but is organized slightly differently. Ketamine contains molecules with two different “orientations,” meaning that their atoms are arranged in a specific way. Esketamine, on the other hand, contains molecules with only one of these orientations.
This chemical difference means that esketamine can be administered through the nose, whereas ketamine must be injected. Esketamine is also more potent, allowing it to be used in smaller doses. (While ketamine is commonly used as an anesthetic, it can be used off-label to treat depression.)
How does esketamine help depression?
It’s not entirely clear how exactly esketamine exerts its antidepressant effects, but it’s thought that the drug affects the transmission of a chemical messenger known as glutamate in the brain, which plays a key role in mood regulation. Traditional antidepressants tend to affect other brain chemicals, such as serotonin and norepinephrine. Esketamine also works differently from so-called classic psychedelics, such as psilocybin and LSD, which affect serotonin signaling.
Following clinical trials, the FDA approved esketamine under the brand name Spravato in 2019. It was initially approved as an “add-on” treatment for patients with TRD who were already taking another oral antidepressant.
More than 80,000 people in the U.S. have already been treated with Spravato, according to the manufacturer. And now, thanks to the latest FDA approval, Spravato can also be used as a stand-alone treatment, potentially opening up new options for more people to try it.
What prompted the new FDA approval?
The new FDA approval came after a clinical trial found that 22.5 percent of patients taking Spravato alone for four weeks achieved remission — in other words, they were essentially free of depressive symptoms — compared with 7.6 percent of patients taking a placebo. There were also no “new safety concerns” associated with using the drug alone versus taking it with another antidepressant.
Sourse: www.livescience.com
