Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for individuals whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients experiencing difficult-to-treat depression often spend too long trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a news release.
The application was accompanied by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with patients showing symptom relief as early as 24 hours after administration and lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target brain chemicals like serotonin and dopamine, Spravato improves the levels of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato have increased by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.