Johnson & Johnson’s Spravato has been approved as the first antidepressant for people who are actively suicidal as doctors are increasingly concerned about the effect of Covid-19 on the mental health of Americans.
Food and Drug Administration approval means the fast-acting nasal spray will be available to people with suicidal thoughts and a plan to implement them, said Michelle Kramer, vice president of the medical affairs unit. American neuroscientists from J&J. This makes up 11% to 12% of the 17 million Americans who suffer from major depressive disorder.
Spravato has been used by around 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 considering suicide goes against a trend among drugmakers who consistently exclude these patients from trials.
Part of the thinking behind the decision was that Spravato’s ability to act quickly could mean it works differently from older antidepressants which can take weeks to kick in, Kramer said. In his studies, J&J found that those who received the drug had a rapid reduction in the severity of their thinking, although the results did not differ statistically significantly from those of patients given a placebo.
Data from studies on the drug show that it “may offer clinicians a new way to quickly provide support to patients in the midst of an urgent depressive episode and help put them on the road to remission,” said Gerard Sanacora, director of Yale’s Depression Research. Program and a test investigator.
America has been in the throes of a suicidal crisis even before the pandemic, with a rate that rose 30% from 1999 to 2016. Covid-19 closures have limited the number of people who received the spray as treatment for the disease. depression in person in specific centers.
Ultimately, however, the numbers improved as patients and centers adjusted and concerns from the mental health community grew that the physical distancing and social isolation of midlife can exacerbate people’s existing problems or introduce new ones.
“Relatively quickly within a few weeks we saw the numbers stabilize, which was quite interesting for us and validated in the sense that the clinic and patients continued to make this available,” Kramer said. “We are certainly seeing more and more sites going online and more and more patients being treated.”
Spravato is a close chemical cousin of the anesthetic ketamine, which differs from existing antidepressants in that it acts on the glutamate system in the brain rather than on seratonin or norepinephrine. Scientists are working to better understand how the drug helps patients and why it works so quickly.
Approval of the drug last year marked the first major breakthrough for depression since 1987. President Donald Trump has since claimed the drug has the potential to curb the suicides of veterans, but a veterans medical committee approved the use of the drug only on a limited basis.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)