Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019, but only in conjunction with an oral antidepressant for patients whose symptoms persisted despite trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with 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 cause 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, could alleviate symptoms in patients as soon as 24 hours after administration and maintained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that typically target serotonin and dopamine levels, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and aids in neuron communication.
Sales figures for Spravato showed a substantial increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.