Reuters
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The U.S. Food and Drug Administration has expanded approval of Johnson & Johnson’s Spravato nasal spray to allow it to be used as a stand-alone treatment for patients with severe depression, the company announced Tuesday.
The ketamine-derived drug was first approved in 2019 for use in combination with antidepressants, then 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,” said Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, in a press release.
Spravato reported revenue of $780 million for the first nine months of 2024.
MDD is one of the most common mental health disorders in the United States, according to the National Institutes of Health. About 21 million American adults in 2021 experienced at least one depressive episode, according to the latest government data.
J&J said about a third of adults won’t respond to oral antidepressants alone.
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Approval of Spravato for stand-alone use is based on a study in which patients treated with the therapy showed rapid and greater improvement in the 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 the anesthetic ketamine, which is also used as a recreational drug and goes by the nickname “Special K.”
J&J said 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.
