FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)

Spravato, the brand name for esketamine, has a newly approved indication for treatment-resistant depression. tadamichi/Getty Images/iStockphoto/iStockphoto hide caption

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The U.S. Food and Drug Administration has expanded its approval of Spravato, an antidepressant nasal spray. The drug is now cleared for use as a standalone treatment for depression.

Spravato is made from esketamine, one of two mirror-image molecules found in the anesthetic ketamine. It was approved in 2019 for use in adults with major depressive disorder who did not respond to at least two other antidepressants.

The original approval required that patients on Spravato also receive an oral antidepressant. Now, the FDA says the drug can be used on its own. The decision came after a large study found that Spravato alone worked better than a placebo. In the first nine months of 2024, the drug generated sales of about $780 million for its maker, Johnson & Johnson.

Spravato is intended to be administered under the direct supervision of a healthcare provider.

In the company's press release announcing the expanded use, it stressed that depression is complicated and the drug could cause, "serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse," so it will continue to be administered in certified treatment centers.

Major depressive disorder affects more than 20 million adults in the U.S. About one in three patients does not respond to oral antidepressants alone.