Nasal spray approved for treating people who are suicidal

Johnson & Johnson’s Spravato has been approved as the first antidepressant for actively suicidal people, as doctors are becoming increasingly concerned about COVID19’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 show 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 had been in the throes of a suicide crisis even before the pandemic, with the rate rising 30% from 1999 to 2016.