Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to serve as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve following two or more antidepressant treatments.
The company noted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed concern for the many patients facing difficult-to-treat depression who often endure prolonged cycles through ineffective treatments, which can impose significant emotional and functional strain on both them and their families.
This new application is supported by data from a late-stage clinical trial showing that Spravato, when used alone, alleviated symptoms in patients within just 24 hours and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which typically affect serotonin and dopamine levels in the brain, Spravato enhances glutamate levels. Glutamate, the brain’s most prevalent neurotransmitter, facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the three-month period ending June 30 compared to the same timeframe in 2022. The treatment has been utilized by over 100,000 patients across 77 countries, according to Johnson & Johnson.