FDA Approves Ketamine-Like Drug for Treatment of Depression

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On March, 2019, the FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults with treatment resistant depression.  The starting dose is 56 mg via nasal spray twice per week and can be titrated to a maintenance dose of 56 or 84 mg once a week or every other week.  Because of the risk of adverse effects and diversion, the drug must be administered during a clinic visit and the patient must be observed for at least 2 hours after the dose.  Esketamine is only available via the REMS program. 

Efficacy was evaluated in three clinical trials where patients were treated for four weeks and one longer-term maintenance trial. In the three short-term studies, patients were randomized to esketamine or placebo nasal spray.   In one of the short-term studies, esketamine nasal spray was significantly more effective in reducing the severity of depression, and some effect was seen within two days. The other two short term studies did not meet efficacy endpoints.  In the longer-term maintenance trial, patients who responded in the short term studies were continued on esketamine or placebo, and those on esketamine had a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray.  

Esketamine has black box warnings for sedation, dissociation, abuse and misuse and suicidal thoughts and behavior.  The most common adverse effects reported in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

FDA press release


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Go to the profile of Jill Kolesar & Lee Vermeulen

Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

3 Comments

Go to the profile of Ngan Hoang
Ngan Hoang 12 days ago

It would be great if someone can help me to understand what is REMS program.
Thanks in advance!


Go to the profile of Jill Kolesar & Lee Vermeulen

Great question! REMS or "Risk Evaluation and Mitigation Strategies" is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns, intended to help ensure the benefits of the medication outweigh its risks.  There are many drugs that require REMS currently.  We will highlight the REMS program in the Drug of the Week next week.

Thanks for asking!

Jill Kolesar and Lee Vermeulen

Go to the profile of Ngan Hoang
Ngan Hoang 12 days ago

Thanks for your reply. This is helpful.