Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in conjunction with an oral antidepressant for individuals whose depression did not improve after trying two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the approximate 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed in a press release that patients facing difficult-to-treat depression often undergo lengthy trials with various treatments that do not effectively alleviate their symptoms, resulting in significant emotional and functional challenges for themselves and their families.
The application to the FDA is backed by data from a late-stage clinical trial, which indicated that Spravato, when used alone, could alleviate symptoms as early as 24 hours post-treatment and maintain its effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that modify serotonin and dopamine levels in the brain, Spravato enhances glutamate levels. Glutamate is the brain’s most prolific neurotransmitter and is essential for neuronal communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. According to Johnson & Johnson, Spravato has been accessed by 100,000 patients across 77 countries.