Esketamine (Spravato), the Antidepressant Nasal Spray, Nears FDA Approval
What is esketamine for?
Intranasal esketamine (brand name Spravato) is to be used in combination with antidepressant pills for difficult-to-treat depression. That is, depression which has not improved despite several back-to-back trials of different antidepressants.
16.2 million (6.7%) U.S. adults have had at least one major depressive episode. Of these, between 30% and 50% will have difficult-to-treat depression. The outlook for these folks is grim, and the risk of suicide is high.
How is esketamine related to ketamine?
If you thought esketamine sounded familiar, here’s why. It’s very closely related to the 50-year-old anesthetic ketamine. Ketamine has other uses too: It is (mis)used as a hallucinogenic party drug. At low doses, it can cause a rush of euphoria, but this can quickly change into “mind/body dissociation”, plunging users into what is known as the “k hole”––a scary state of near-paralysis somewhere between intoxication and coma.
Esketamine, a drug patented by Johnson & Johnson, is a molecule extracted from the ketamine molecule (ketamine is a mixture of two mirror-image molecules, and esketamine is one of them). It has the same effects as ketamine: It is a fast-acting antidepressant, which becomes hallucinogenic at higher doses.
How well does esketamine work compared to other popular antidepressants?
Traditional antidepressant pills can take 2-4 weeks to take effect. Several weeks can be a long time to wait for an improvement in symptoms, especially if the antidepressant causes side effects such as nausea, stomach upset, dry mouth, sleeplessness or drowsiness––which many do. Add to that frustration the fact that 60%-70% of sufferers will not respond to the first treatment they try, and the situation can get pretty desperate.
The main benefit of esketamine is that it causes a fast––within hours and days––improvement in the symptoms of depression. This is a major shift in treatment options for sufferers who could feel that they are running out of options. The nasal spray helps esketamine get absorbed faster than taking a pill. It is given––in the doctor’s office––twice a week for the first month, and then every week or every other week after that.
So, a new antidepressant that works fast to save lives where others fail? What’s not to be excited about?
What are common side effects of esketamine?
Esketamine is not a miracle drug. It has a high risk for misuse, and higher doses can cause a frightening and dangerous state of “mind-body dissociation”, where the user cannot speak or move and can become psychotic or comatose in extreme cases.
Even under a doctor’s supervision, there is a risk of blood pressure spikes and distressing, “out-of-body” experiences, as well as headaches and nausea.
The thing that concerns experts most about esketamine is the absence of long-term evidence about its safety.
There is also the fact that this new treatment plays into the current hype surrounding ketamine as some kind of miracle cure for depression. Experts worry that the hype will discourage depression sufferers from trying traditional, safer, first-line antidepressants, favoring instead the “quick fix” promised by esketamine.
When will esketamine be FDA approved?
An independent advisory committee of expert psychiatrists voted 14 to 2 in favor of approving intranasal esketamine for the treatment of depression on February 12, 2019. The final FDA decision is expected by March 4, 2019, and approval is likely.
How much will esketamine nasal spray cost?
There is no information yet on how much Spravato will cost, but we’ll be sure to announce prices once the drug is approved. Popular antidepressants like sertraline (Zoloft), fluoxetine (Prozac), escitalopram (Lexapro), and duloxetine (Cymbalta) currently cost about $10-$20 with a GoodRx coupon for a typical 30-day supply.
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