On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray to be used alone in adults with major depressive disorder.
The spray, called Spravato, is now the first-ever standalone therapy for treatment-resistant depression. This is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
According to CNBC, Spravato was cleared in the U.S. to use together with an oral antidepressant for both treatment-resistant depression and for people with major depressive disorder who are experiencing thoughts of suicide or harm.
“We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview with the outlet.
FEELING DEPRESSED? USE NASAL SPRAY: The FDA approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat.
— Breaking911 (@Breaking911) January 21, 2025
The spray, called Spravato, is now the first-ever standalone therapy for treatment-resistant depression. pic.twitter.com/ZPoAO15MOV
Reportedly, about one-third of the estimated 21 million U.S. adults with major depression battle symptoms don’t respond to treatment.
“For the first time ever, we now have an option that gives patients freedom,” Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials, said.
Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills aren’t improving their symptoms and are causing undesirable side effects.
The approval of Spravato was based on a phase four trial that showed that Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. The drug first entered the US market in 2019.