Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depressive symptoms failed to improve after trying two or more other antidepressants.
The company indicated that nearly 30 percent of the approximately 280 million people worldwide diagnosed with major depressive disorder experience 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 cause a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA was accompanied by findings from a late-stage clinical trial that revealed Spravato, when used as a standalone therapy, demonstrated the ability to alleviate symptoms as early as 24 hours post-treatment and sustained improvement for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a medical setting. Unlike conventional antidepressants that target serotonin and dopamine levels, Spravato operates by enhancing glutamate activity in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 patients across 77 countries, as stated by Johnson & Johnson.