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-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure lengthy periods cycling through various treatments that fail to alleviate their symptoms, leading to significant functional and emotional strain on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as early as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a medical professional. Unlike typical antidepressants that adjust neurotransmitters like serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.