FDA approves Johnson & Johnson’s nasal spray for depression as stand-alone treatment
Posted on January 23, 2025
Source:
CNBC
- The Food and Drug Administration approved Johnson & Johnson’s nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow.
- The spray, called Spravato, is now the first-ever stand-alone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
- Spravato is on its way to becoming a blockbuster product, with the drug bringing in $780 million in sales during the first nine months of 2024 as doctors grow more comfortable using it.
The Food and Drug Administration on Tuesday approved Johnson & Johnson
’s nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow.
The spray, called Spravato, is now the first-ever stand-alone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
Previously, 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. The drug first entered the U.S. market in 2019.
“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.
Around one-third of the estimated 21 million U.S. adults with major depression battle symptoms — such as persistent feelings of sadness, sleep disturbances, low energy, and thoughts of death or suicide — that don’t respond to treatment, according to some estimates.
“For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials.
His center in St. Louis has treated more than 6,000 patients with the drug, and currently just over 100 people are taking it there. That is one of 3,000 outpatient treatment centers in the U.S. that are certified to administer Spravato, according to J&J’s tally.
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, such as weight gain and sexual issues.
J&J’s Martin said the approval provides “an avenue for caregivers and their patients to really optimize, personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease.
That could potentially “open up the number of patients who could benefit” from Spravato, according to Martin.