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 drug, Spravato, allowing it to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato received its initial FDA approval in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
Johnson & Johnson indicated that nearly 30 percent of the estimated 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
“Numerous patients with difficult-to-treat depression often spend excessive time trying various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission to the FDA includes data from a late-stage clinical trial that demonstrated that Spravato, when used alone, could begin reducing patients’ symptoms as quickly as 24 hours after treatment and maintain its effects for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. In contrast to other antidepressants that modify chemicals such as serotonin and dopamine in the brain, Spravato enhances levels of glutamate, the most prevalent neurotransmitter, which is vital for neuronal communication.
In the second quarter of 2023, Spravato sales surged by 60%, reaching $271 million compared to the same quarter the previous year. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.