Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, for use as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
“Patients facing difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional distress for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, was effective in reducing symptoms as early as 24 hours post-treatment and maintained benefits for at least four weeks.
Spravato is administered as a nasal spray and needs to be taken under the supervision of a healthcare provider. Unlike conventional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato works by increasing levels of glutamate in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato increased by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has been used by over 100,000 patients across 77 countries, according to the company.