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 be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after taking two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with hard-to-treat depression often spend too much time trying various treatments that don’t effectively alleviate their symptoms, which can create significant emotional and functional burdens for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was accompanied by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate patients’ symptoms as quickly as 24 hours following administration and continued to do so for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical environment. Unlike other antidepressants that mainly affect brain chemicals such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter in the brain, facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.