Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to serve as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve with at least two other antidepressant medications. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can impose a significant functional and emotional burden on patients and their loved ones.”
The application includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can significantly alleviate patients’ symptoms within 24 hours and maintain this effect for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike other antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
In the second quarter of this year, sales of Spravato surged by 60% to $271 million compared to the same period in 2023. The drug has been utilized by a total of 100,000 patients across 77 countries, according to Johnson & Johnson.