FDA Approves Standalone Use of Johnson & Johnson’s Depression Nasal Spray

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has expanded its approval of Johnson & Johnson‘s nasal spray, Spravato, allowing it to be used as a standalone treatment for severe depression, the company announced Tuesday. The drug, derived from ketamine, was previously approved in 2019 for use alongside antidepressants and later for patients with suicidal thoughts.

“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs,” said Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, in a statement. Spravato generated $780 million in sales during the first nine months of 2024, according to Johnson & Johnson.

Major depressive disorder (MDD) is one of the most common mental health conditions in the U.S., affecting approximately 21 million adults in 2021, according to the National Institutes of Health. About one-third of adults do not respond to oral antidepressants alone, the company noted.

The FDA’s decision follows a large study showing that Spravato alone was more effective than a placebo. The drug, which contains esketamine, a derivative of ketamine, must be administered under the supervision of a healthcare provider in certified treatment centers due to potential side effects, including sedation, dissociation, and respiratory depression.

Spravato’s expanded approval marks a significant step in addressing treatment-resistant depression, a condition that affects millions of Americans. The drug’s unique mechanism of action offers hope for patients who have not found relief through traditional antidepressants.