The Impending FDA Approval of Esketamine and What It Means for Depression Treatment

Since it was developed in 2016, we’ve blogged several times about esketamine—the isomer of ketamine being developed by Janssen Pharmaceuticals, designed to rapidly alleviate the symptoms of treatment-resistant depression. Esketamine, which will be administered intranasally, was granted breakthrough medication status by the FDA and fast-tracked for approval. And the time for approval is here.

In the next few weeks we will know whether or not esketamine has earned official FDA approval. If approved, it will be the most eagerly anticipated new depression treatment introduced to the market in decades.

In the studies done on Esketamine, the most common side effects were increases in blood pressure and feelings of dissociation However, almost every useful prescription drug carries some consequence—it’s a matter of whether the benefits outweigh the risks, and in the case of esketamine, FDA medical experts voted 14-2 that they do.

However, for all the support esketamine has received—and all the media attention—there are many important unanswered question:

1. By whom will esketamine be administered? Studies indicate that esketamine is most effective when administered 2x/week during the first month, and then 1x/week or every other week during the maintenance phase. We know that esketamine will not be available for patients to use at home--it must be given by a healthcare professional in a medical office--but we don't know what types of healthcare providers will be certified to administer the drug.

2. How long will patients stay on esketamine, and what are the long-term risks?

3. Has the bar been set too high? There has been a lot of media attention surrounding ketamine and esketamine for depression. However, some of the positive results have been exaggerated, and there is so much hype…medical experts are concerned that patients will have unrealistic expectations about the effectiveness of esketamine.

One of the more positive aspects of esketamine receiving FDA approval will be that insurance companies, under the right circumstances, will cover the cost of the medication. Ketamine infusions are available at private clinics across the country—clinics like ours—though not many insurance providers are willing to cover the cost. The affordability of esketamine could make it available and accessible to so many more people who truly need it.

One thing that we want to make sure patients understand about esketamine is that, like ketamine, it is not a first-line depression treatment. It will not replace talk therapy or traditional antidepressant drugs. In fact, esketamine is often used in conjunction with traditional antidepressants, and is recommended for patients who are unable to find relief through other depression treatments.

Esketamine could change the landscape of depression treatment as we know it, but there are still many questions. Keep checking in with our blog—we’ll keep you posted on the latest developments and news. While we await the FDA’s decision, ketamine infusions are still available at either of our Colorado locations. To learn more about ketamine infusions and find out if you’re a candidate, complete the brief form below and a member of our team will get in touch with you!

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