Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval of its ketamine-based drug, Spravato, to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms persist despite trying at least two different antidepressants.
The company noted that nearly 30 percent of the estimated 280 million individuals globally living with 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 application to the FDA is supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained this improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in an appropriate medical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
The sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the drug has been prescribed to 100,000 patients across 77 countries.