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 drug, Spravato, to allow it to be administered 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 symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
“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,” commented Bill Martin, head of neuroscience at Johnson & Johnson.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms within 24 hours and provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a medical facility. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same quarter in 2022. To date, Spravato has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.