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, allowing it to be utilized as a standalone treatment for 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 symptoms failed to improve after undergoing two or more antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from 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 for expanded approval includes findings from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with symptom relief observed as soon as 24 hours after administration and lasting for at least four weeks.
Spravato is administered as a nasal spray in a healthcare setting, under the guidance of a healthcare provider. Unlike typical antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to reach $271 million for the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.