FDA Greenlights J&J’s Ketamine-Based Treatment for Depression as Standalone Therapy
The FDA has expanded approval for Johnson & Johnson's nasal spray, Spravato, allowing it to be used as a standalone treatment for severe depression. The ketamine-derived drug shows rapid improvement in depressive episodes, offering new options for patients who don't respond to traditional antidepressants.

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 on Tuesday. Initially approved in 2019 for use alongside antidepressants and later for patients experiencing suicidal thoughts or behaviors, the ketamine-derived drug can now be prescribed as monotherapy.
This approval gives healthcare providers greater flexibility to tailor treatment plans to individual patient 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. Major depressive disorder (MDD), one of the most prevalent mental health conditions in the U.S., affected approximately 21 million adults in 2021, according to the National Institutes of Health. Johnson & Johnson noted that about one-third of adults with depression do not respond to oral antidepressants alone.
Spravato’s approval for standalone use is supported by a study in which patients treated with the drug showed rapid and significant improvement in the severity of depressive episodes compared to a placebo. More than 20% of patients on Spravato achieved remission, according to the company.
The drug targets the neurotransmitter glutamate, which is crucial for various brain functions. Esketamine, the active ingredient in Spravato, is a chemical mirror image of ketamine, an anesthetic also known as the recreational drug Special K.
While the exact mechanism through which esketamine produces its antidepressant effects remains unclear, Johnson & Johnson has emphasized that due to the risk of misuse, Spravato is available only through a restricted distribution program.
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