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, so that it may be utilized 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, aimed at patients whose depression symptoms did not improve with two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide affected by 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 submission included data from a late-stage clinical trial demonstrating that Spravato as a standalone treatment alleviated patients’ symptoms as early as 24 hours post-treatment, with effects lasting for at least four weeks.
Administered as a nasal spray, Spravato requires supervision from a healthcare provider within a healthcare setting. Unlike traditional antidepressants that adjust serotonin and dopamine levels in the brain, Spravato enhances glutamate levels, the brain’s most abundant neurotransmitter, to improve neuronal communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of 2023, compared to the same period last year, and the medication has been used by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.