FDA Approves Stand-Alone Use of Antidepressant Nasal Spray Spravato (Esketamine): Shots

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

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

The initial approval required that patients taking Spravato also receive an oral antidepressant. Now, the FDA says the drug can be used alone. The decision came after a large study found that Spravato alone was more effective than a placebo. Through the first nine months of 2024, the drug generated sales of about $780 million for its manufacturer, Johnson & Johnson.

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

In the company’s press release announcing the expanded use, it noted that depression is complicated and that the drug could cause “serious adverse reactions resulting from sedation, dissociation, respiratory depression, abuse and misuse. treatment centers.

Major depressive disorder affects more than 20 million adults in the United States. About one in three patients do not respond to oral antidepressants alone.