Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the expansion of its ketamine-based medication, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients who had not responded to two or more other antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed in a press release that “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 impose a significant functional and emotional burden on patients and those close to them.”
The application includes findings from a late-stage clinical trial which demonstrated that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after administration and maintained effectiveness for at least four weeks of treatment.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.