J&J's ketamine-derived nasal spray approved by FDA to treat depression
The Food and Drug Administration (FDA) approved Johnson & Johnson's ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression.
Spravato, approved as a standalone treatment, is "the first and only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants," the pharmaceutical giant said Tuesday.
An estimated 21 million adults in the U.S. are living with major depressive disorder, one of the most common psychiatric disorders, but one-third of them will not respond to oral antidepressants alone, hindering their quality of life, according to Johnson & Johnson.
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"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement," Bill Martin, global therapeutic area head of Neuroscience at Johnson & Johnson Innovative Medicine, said in a statement.
Patients could experience improvements in their symptoms as early as 24 hours without the need for daily oral antidepressants.
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The approval, granted following FDA priority review, comes after more than a decade of research and almost six years of real-world evidence. As of Tuesday, it has been administered to more than 140,000 patients worldwide.
The drug "has proven to be a transformational treatment option for many patients with TRD by reducing depression symptoms in as little as 24 hours and reducing the time to relapse for patients who stay on treatment," the company said.
There has been a growing use of using ketamine – described as a "dissociative drug" – to combat depression. It also made headlines due to its use by high-profile figures, including Elon Musk.
In March 2024, the head of Tesla and SpaceX said in an interview that he uses ketamine to boost his mental health.
"There are times when I have sort of… a negative chemical state in my brain, like depression, I guess," Musk said, adding that he uses a "small amount once every other week."
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"Ketamine is useful for getting one out of a negative frame of mind," Musk went on, referring to his depression as "chemical tides" and saying it wasn’t "negative news."
However, off-label use of the drug has "skyrocketed" in recent years, "despite limited data supporting the safety and efficacy of that practice," according to a report from Yale School of Medicine.
FOX News' Melissa Rudy contributed to this report.