The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine 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.
About 21 million U.S. adults 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 .
“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 provide patients with much-needed symptom relief,” Bill Martin, head of global therapeutics neuroscience at Johnson & Johnson Innovative Medicine, said in a statement.
Patients can experience improvements in their symptoms as early as 24 hours without the need for daily oral antidepressants.
The approval, granted after FDA priority review, comes after more than a decade of research and nearly six years of real-world trials. As of Tuesday, it has been administered to more than 140,000 patients worldwide.
The drug “has proven to be a transformative treatment option for many TRD patients by reducing depressive symptoms in as little as 24 hours and reducing relapse time for patients who remain on treatment,” the company said.
There has been a growing use of ketamine – described as a “detachment drug” – to combat depression. It also made headlines for 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 enhance his mental health.
“There are times when I have some kind of… a negative chemical state in my brain, like depression, I guess,” Musk said, adding that he uses a “small amount once a week.”
“Ketamine is useful for getting a person out of a negative mindset,” Musk continued, referring to his depression as a “chemical tide” 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 this practice,” according to a report from the Yale School of Medicine.
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