Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-derived medication, Spravato, to allow it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA originally approved Spravato in 2019 as part of a treatment plan alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more other antidepressant medications.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 Spravato’s expanded use was supported by data from a late-stage clinical trial, which indicated that the medication, when used alone, alleviated symptoms for patients as quickly as 24 hours post-treatment and maintained that relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate levels. Glutamate serves as the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same quarter in 2023. The medication has been prescribed to approximately 100,000 patients across 77 countries, according to Johnson & Johnson.