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, as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially designated for use in conjunction with an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants.
Johnson & Johnson noted that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 to the FDA included data from a late-stage clinical trial indicating that Spravato, used alone, alleviated symptoms in patients as soon as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be used under health care supervision. Unlike many traditional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is a crucial neurotransmitter for neuron communication.
In recent financial results, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.