Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the application of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients who did not respond to two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the global population living with major depressive disorder, estimated at 280 million individuals, experiences 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 the expanded use of Spravato is supported by data from a late-stage clinical trial that indicated the medication effectively alleviated symptoms in patients as soon as 24 hours after administration and maintained its effectiveness for at least four weeks.
Spravato is administered via nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that typically adjust brain chemicals such as serotonin and dopamine, Spravato increases levels of glutamate in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In financial terms, sales of Spravato experienced a significant increase of 60%, reaching $271 million in the three months ending June 30, when compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.