Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant, targeting patients whose symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson stated that nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, emphasized the struggle many patients face, saying, “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 was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, demonstrated improvements in patient symptoms as quickly as 24 hours post-treatment and maintained efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider within a clinical setting. Unlike traditional antidepressants that modify neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the primary neurotransmitter responsible for facilitating communication between neurons.
In terms of sales, Spravato experienced a remarkable 60% increase, generating $271 million in revenue during the three months ending June 30, compared to the same quarter in 2023. According to Johnson & Johnson, the medication has been utilized by around 100,000 individuals across 77 countries.