FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration 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 company said on Tuesday.
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.
“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs,” Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, said in a statement.
Spravato bought in sales of $780 million for the first nine months of 2024.
MDD is one of the most common mental health disorders in the U.S., according to the National Institutes of Health. About 21 million U.S. adults in 2021 experienced at least one depressive episodes, latest government data shows.
J&J said that about a third of adults will not respond to oral antidepressants alone.
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Spravato’s approval for standalone use is based on a study in which patients treated with the therapy showed a rapid and superior improvement in severity of depressive episodes, compared to placebo.
More than a fifth of patients taking Spravato went into remission, the company said.
The drug works by targeting a 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.
