Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients who had not experienced improvement after trying two or more antidepressants.
Johnson & Johnson noted that around 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, resulting in considerable functional and emotional challenges for them and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, provided symptom relief for patients as quickly as 24 hours after treatment and sustained improvement for at least four weeks.
Spravato is administered as a nasal spray and must be used in a healthcare setting under the supervision of a healthcare provider. Unlike conventional antidepressants that target neurotransmitters such as 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% to $271 million in the quarter ending June 30 compared to the same period in 2022. The drug has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.