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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. 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..
