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Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-based nasal spray to help millions of American patients suffering from severe depression.
Spravato, approved as a stand-alone 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 US live with major depressive disorder, one of the most common psychiatric disorders, but one-third of them will not respond to oral antidepressants alone, hampering 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 or cannot tolerate oral antidepressants. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, global neuroscience therapist leader at Johnson & Johnson Innovative Medicine, said in a statement.
Patients could experience improvement of their symptoms for 24 hours without the need for daily oral antidepressants.
Johnson & Johnson’s recently approved nasal spray, Spravato. (Johnson & Johnson)
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The approval, granted after FDA priority review, comes after more than a decade of research and nearly six years of real-world evidence. By Tuesday, it had been administered to more than 140,000 patients worldwide.
The drug “has proven to be a transformational treatment option for many TRD patients by reducing depressive symptoms in as little as 24 hours and shortening the time to relapse for patients who remain on treatment,” the company said.
Ketamine – described as a “dissociative drug” – is increasingly being used to combat depression. It has also made headlines for being used by high-profile figures, including Elon Musk.
The Johnson & Johnson Building in Irvine, California on January 24, 2017. (Mike Blake/File/Reuters photos)
In March 2024. head of Tesla and SpaceX he said in an interview that he uses ketamine to boost his mental health.
“There are times when I have some kind of … 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 out of a negative state of mind,” Musk continued, calling his depression a “chemical tide” and saying it wasn’t “negative news.”
However, off-label use of the drug has “increased” in recent years, “despite limited data supporting the safety and efficacy of the practice,” according to a Yale School of Medicine report.
FOX News’ Melissa Rudy contributed to this report.
