Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone therapy for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms remained unchanged after trying two or more other antidepressants.
According to Johnson & Johnson, approximately 30 percent of the 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 is supported by findings from a late-stage clinical trial indicating that Spravato, when used alone, was effective in alleviating symptoms as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a medical professional. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, the most abundant neurotransmitter, which facilitates communication between neurons.
In a related development, sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.