Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) aiming to expand the approval of its ketamine-based drug, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide affected by 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, stating that many often go through prolonged periods of ineffective treatments, leading to significant emotional and functional challenges for both themselves and their families.
The submission to the FDA includes data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, significantly alleviated symptoms as soon as 24 hours after administration and continued to show effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Spravato’s sales have seen a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.