J&J’s ketamine-derived nasal spray is approved to treat depression

Food and Drug Administration (FDA) Johnson & Johnson has approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of American patients with major depression.

Spravato, which has been approved as a standalone treatment, 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.

An estimated 21 million adults in the United States have 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 complex, especially for patients who do not respond to or cannot tolerate oral antidepressants. For too long, health care providers have had few options to provide patients with the symptom relief they desperately need. said Bill Martin, global treatment expert. Head of Neuroscience at Johnson & Johnson Innovative Medicines said in a statement:

Patients can experience Improvement in their symptoms As early as 24 hours without the need for daily oral antidepressants.

The doctor warns that mail-order ketamine injections can be “extremely dangerous.” Mark Siegel

The approval, granted after a review of FDA priorities, comes after more than a decade of research and nearly six years of real-world evidence. As of Tuesday, it had been given to more than 140,000 patients around the world.

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 time to relapse for patients who continue treatment,” the company said.

There has been increasing use of ketamine – described as a “dissociative drug” – to combat depression. It has also made headlines due to its use by high-profile figures, including Elon Musk.

In March 2024, Chairman of Tesla and SpaceX He said in an interview that he uses ketamine to boost his mental health.

“There are times when I feel a negative chemical state in my brain, like depression, I guess,” Musk said, adding that he uses “a small amount once every two weeks.”

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“Ketamine is helpful in getting a person out of a negative state of mind,” Musk went on to say, referring to his depression as a “chemical tide” and saying it’s not “negative news.”

However, off-label use of the drug “has risen dramatically” in recent years, “despite limited data supporting the safety and effectiveness of the practice,” according to a report from Yale University School of Medicine.

Fox News’ Melissa Ruddy contributed to this report.