[The U.S. Food and Drug Administration has expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression. The ketamine-derived drug was first approved in 2019 to be used in combination with antidepressants, and later for patients experiencing suicidal thoughts or actions.
Spravato brought in sales of $780 million for the first nine months of 2024. Major depressive disorder (MDD) is one of the most common mental health disorders in the U.S., with about 21 million U.S. adults experiencing at least one depressive episode in 2021, latest government data shows. About a third of adults will not respond to oral antidepressants alone.
The approval for standalone use is based on a study in which patients treated with the therapy showed a rapid and superior improvement in the severity of depressive episodes, compared to a placebo. More than a fifth of patients taking Spravato went into remission, the company said.
Spravato works by targeting the neurotransmitter glutamate, which plays a key role in functions. Esketamine, the chemical name for Spravato, is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational party drug and goes by the street nickname “Special K.”
J&J said that the mechanism by which esketamine exerts its antidepressant effect is unknown. Due to the potential risk of misuse, Spravato is only available through a restricted program. Healthcare providers now have the freedom to further personalize treatment plans based on individual needs, according to Gregory Mattingly, founding partner of St. Charles Psychiatric Associates.
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