Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, so it can be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve despite trying two or more other antidepressants.
According to Johnson & Johnson, 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, emphasized the challenges faced by patients with difficult-to-treat depression, noting that many spend excessive time trying various treatments without success, leading to significant emotional and functional burdens on them and their families.
The application to the FDA includes data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that work by affecting neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a crucial role in facilitating communication between neurons.
Moreover, sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that Spravato has been administered to 100,000 patients across 77 countries.