FDA Approves Ketamine-Like Drug for Treatment of Depression

FDA Approves Ketamine-Like Drug for Treatment of Depression
Like

Share this post

Choose a social network to share with, or copy the URL to share elsewhere

This is a representation of how your post may appear on social media. The actual post will vary between social networks

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


Additional information about legitimate and safe antidepressants can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Flash Card section.  If your institution does not provide access, ask your medical librarian about subscribing.

For a chance to win GREAT prizes and learn more about medications in the Top 300, check out the Drug Card Scavenger Hunt page on AccessPharmacy. Follow us to receive email alerts when new Drug of the Week and Drug Card Scavenger Hunt updates are posted.

Create a Free MyAccess Profile

AccessMedicine Network is the place to keep up on new releases for the Access products, get short form didactic content, read up on practice impacting highlights, and watch video featuring authors of your favorite books in medicine. Create a MyAccess profile and follow our contributors to stay informed via email updates.

Go to the profile of Ngan Hoang
over 5 years 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
over 5 years ago

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
over 5 years ago

Thanks for your reply. This is helpful.