Cardiol Therapeutics Inc.
Food and Drug Administration (FDA) It approved Johnson & Johnson's ketamine-derived nasal spray to help millions of American patients suffering from major depression.
Approved as a stand-alone treatment, Spravato is “the first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants,” the pharmaceutical giant said Tuesday.
About 21 million adults in the United States live with major depressive disorder, one of the most common psychiatric disorders, but one-third do not respond to oral antidepressants alone, impairing their quality of life, according to Johnson & Johnson. slow
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“Treatment-resistant depression can be very complex, especially for patients who do not respond to or cannot tolerate oral antidepressants. For a long time, health care providers have had few options,” said Bill Martin, MD, MD, MD. to provide symptom relief to patients.” regional head of neuroscience at Johnson & Johnson Innovative Medicine said in a statement.
Patients could experience Improve their symptoms Up to 24 hours without the need for daily oral antidepressants.
Johnson & Johnson's recently approved nasal spray, Spravato. (Johnson and Johnson)
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The approval, which was issued after an FDA priority review, came after more than a decade of research and nearly six years of real-world evidence. As of Tuesday, the drug has been prescribed to more than 140,000 patients worldwide.
The drug has proven to be a transformative treatment option for many patients with TRD by reducing depressive symptoms in less than 24 hours and reducing the time to relapse for patients who are treated, the company said.
There is a growing use of ketamine – described as a “disintegration drug” – to combat depression. It also made news due to the use of famous figures including Elon Musk.
A Johnson & Johnson building in Irvine, California, January 24, 2017. (Mike Blake/File/Reuters photo)
In March 2024, President of Tesla and SpaceX In an interview, he said that he uses ketamine to improve his mental health.
“There are times when I have a negative chemical state in my brain, like depression, I guess,” Musk said.
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Referring to his depression as a chemical tide, Musk went on to say that ketamine is good for getting out of a negative mindset, and that this is not bad news.
However, “despite limited data supporting the safety and efficacy of the practice,” off-label use of the drug has “risen” in recent years, according to a Yale School of Medicine report.
Fox News' Melissa Rudy contributed to this report.