Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to extend the approved use of its ketamine-based medication Spravato for use as a standalone therapy in treating resistant depression.
The FDA initially approved Spravato in 2019, allowing it to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the 280 million people worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
“Many patients with difficult-to-treat depression spend excessive time going through various treatments that fail to alleviate their symptoms, creating a substantial emotional and functional burden for themselves and their families,” commented Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours following treatment and continued to be effective for at least four weeks.
Spravato, administered as a nasal spray, must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that the medication has been used by 100,000 individuals across 77 countries.