J&J ketamine-derived nasal spray approved to treat depression

Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of US patients suffering from major 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.

According to Johnson & Johnson, about 21 million adults in the U.S. live with major depressive disorder, one of the most common psychiatric disorders, but one-third of them do not respond to oral antidepressants alone, impairing their quality of life.

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“Treatment-resistant depression can be very difficult, especially for patients who don’t respond to or can’t tolerate oral antidepressants. For too long, health care providers have had few options to offer patients relief,” Bill Martin, MD, Johnson & Johnson Chief of Neurology at Innovative Medicine, the statement said.

Patients could feel improving their symptoms in as little as 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 granted after an FDA priority review, comes after more than a decade of research and nearly six years of real-world evidence.As of Tuesday, it has been used in more than 140,000 patients worldwide.

The drug has “proven to be a transformative treatment option for many patients with TRD, reducing symptoms of depression in just 24 hours and reducing the time to relapse for patients who continue treatment,” the company said.

Ketamine, described as a “dissociative drug,” is on the rise to treat depression, and has also made headlines thanks to its use 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. The head of Tesla and SpaceX said in an interview that he uses ketamine to improve his mental health.

“There are times when I have a kind of … negative chemical state in my brain, like depression,” Musk said, adding that he uses “a small amount once a week.”

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“Ketamine is good for getting a person out of a negative mindset,” Musk continued, calling his depression “chemical waves” and saying it’s not “negative news.”

However, off-label use of the drug has “increased” in recent years, “despite limited data supporting the practice’s safety and efficacy,” according to a Yale School of Medicine report.

FOX News’ Melissa Rudy contributed to this report.