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

The U.S. Food and Drug Administration has expanded its approval of the antidepressant nasal spray Spravato. This drug is currently approved for use as a sole treatment for depression.

Spravato is made from esketamine, one of two mirror-image molecules 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 original approval also required Spravato’s patients to receive an oral antidepressant. Currently, the FDA says the drug can be used alone. This decision was made after a large study found that Spravato alone was more effective than a placebo. In the first nine months of 2024, the drug generated sales of about $780 million for manufacturer Johnson & Johnson.

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

inside the company press release In announcing its expanded use, it said that because depression is complex and the drug can cause “sedation, dissociation, respiratory depression, and serious adverse outcomes that can result from abuse or misuse,” certified treatment centers must He emphasized that the vaccine will continue to be administered.

Major depressive disorder affects more than 20 million adults in the United States, and approximately one in three patients does not respond to oral antidepressants alone.