Johnson & Johnson's Spravato has been approved as the first antidepressant for actively suicidal people, as doctors are becoming increasingly concerned about Covid-19's effect on the mental health of Americans.
The Food and Drug Administration approval means the quick-acting nasal spray will be available to people with suicidal thoughts and a plan to put them into action, said Michelle Kramer, vice president of J&J's U.S. neuroscience medical-affairs unit. That constitutes 11% to 12% of as many as 17 million Americans who have major depressive disorder.
Spravato has been used by about 6,000 people for treatment-resistant depression since its approval in March 2019, Kramer said. J&J's decision to study it in depressed people actively contemplating suicide bucks a trend among drugmakers who routinely exclude such patients from trials.
Part of the thinking behind the decision was that Spravato's ability to act quickly could mean it works differently than older antidepressants that can take weeks to kick in, Kramer said. In its studies, J&J found those who got the drug had a rapid reduction in the severity of their thinking, although the results didn't differ in a statistically significant way from patients given a placebo.
The data from studies of the drug shows it "may offer clinicians a new way to provide support to patients quickly in the midst of an urgent depressive episode and help set them on the path to remission," said Gerard Sanacora, director of Yale's Depression Research Program and a trial investigator.
America has been in the throes of a suicide crisis even before the pandemic, with the rate rising 30% from 1999 to 2016. Covid-19 closures limited the number of people given the spray as a depression treatment in-person at specified centers.
Ultimately, though, the numbers improved as patients and centers adapted and concerns grew within the mental health community that physical distancing and social isolation of quarantine may exacerbate people's existing problems or introduce new ones.
"Relatively rapidly within a few weeks we saw the numbers stabilize, which was pretty interesting for us and validating in the sense that clinic and patients alike were continuing to make this available," Kramer said. "We certainly see more and more sites sign on and more and more patients are treated."
Spravato is a close chemical cousin of the anesthetic ketamine, which differs from existing antidepressants because it acts on the glutamate system in the brain rather than on seratonin or norepinepherine. Scientists have been working to better understand how the drug helps patients and why it works so quickly.
The drug's approval last year marked the first major breakthrough for depression since 1987. President Donald Trump has since trumpeted the drug as having the potential to curb veteran suicides, but a Veterans Affairs medical panel only approved the drug's use on a limited basis.
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