Esketamine nasal spray approved by FDA

The U.S. Food and Drug Administration (FDA) announced yesterday that it has approved esketamine nasal spray (brand name Spravato) for marketing in the US. Here are some basic details about this medication:

– What is esketamine? It is one of the two enantiomers in the medication ketamine, which has been available in the US since 1970 and is FDA-approved for use as a general anesthetic.

– Esketamine nasal spray is approved for the treatment of major depressive disorder in persons who have taken other antidepressant medications but have not benefited from them, so-called “treatment-resistant depression.”

– It is approved not for monotherapy but for adjunctive use along with an oral antidepressant medication.

– It is approved for use in adults only

– Not everyone will be able to prescribe esketamine nasal spray. Similar to medications like clozapine and flibanserin, esketamine nasal spray will only be available by prescription from clinicians registered under a Risk Evaluation and Mitigation Strategy (REMS) program. This is because serious adverse events can occur due to sedation and dissociation caused by esketamine and due to the potential for abuse.

– The manufacturer of Spravato is Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson.

– Members of Simple and Practical Mental Health will receive a detailed review of this medication, the research behind, the potential risks, and so on.

The FDA’s announcement is available at the link below:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632761.htm

The full Prescribing Information is available at the link below:

https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf

Disclosure: Dr. Mago bought some J&J stock (less than $7000 worth) and, as in almost all his investments, has lost money on it! He does not have any other association, financial or otherwise, with Janssen Pharmaceuticals, Inc, or its parent company, Johnson & Johnson.