The US Food and Drug Administration has approved Johnson & Johnson’s nasal spray, called Spravato, as a stand-alone treatment for adults with major depressive disorder that is difficult to treat. The approval makes Spravato the first-ever therapy for this type of depression.
Spravato is effective in improving depressive symptoms within 24 hours after treatment and lasting at least one month. According to Johnson & Johnson, the drug’s safety profile is consistent with previous clinical data on its use in combination with oral antidepressants.
The approval is based on a phase four trial that showed Spravato alone improved depressive symptoms in patients who did not respond to standard treatments. The company has reported $780 million in sales for the first nine months of 2024, and expects sales to increase to between $1 billion and $5 billion annually.
Spravato was initially approved in 2019 as a treatment for depression that is accompanied by suicidal thoughts or harm. However, the new approval allows doctors to use it alone as a treatment for patients who have not responded to standard treatments.
According to Dr. Gregory Mattingly, a physician involved in Spravato’s clinical trials, the drug provides “freedom” for patients with treatment-resistant depression. He notes that Spravato can be used with or without oral antidepressants, especially if those medications are causing side effects.
The approval of Spravato is significant, as it provides an option for patients who have not responded to standard treatments. Johnson & Johnson’s CEO, Bill Martin, says the approval will “optimize and personalize” treatment for each individual patient.
Spravato has been shown to have rapid symptom relief, with patients often feeling better within a day or two of treatment. The drug is related to ketamine, but works differently in the brain, according to Mattingly.
The approval comes as Spravato is on track to become a blockbuster product, with sales expected to increase significantly in the coming years. Johnson & Johnson has reported that over 6,000 patients have been treated with the drug, and it is now available at over 3,000 outpatient treatment centers across the US.
Overall, the approval of Spravato represents an important milestone in the treatment of depression, providing a new option for patients who have not responded to standard treatments.
Source: https://www.cnbc.com/2025/01/21/fda-approves-johnson-johnson-nasal-spray-spravato-for-depression.html