Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressants. The drug is seen as a potential lifeline for the nearly 30 percent of the 280 million people worldwide affected by major depressive disorder who suffer from treatment-resistant depression, according to the company.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the struggle of patients enduring lengthy cycles of ineffective treatments, which impose emotional and functional burdens on them and their families.
The application for expanded use is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms as soon as 24 hours after administration and maintain 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 medical setting. Unlike traditional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales figures for Spravato have surged, with a 60% increase to $271 million in the second quarter of 2023 compared to the same period in the previous year. The drug has been utilized by approximately 100,000 patients across 77 countries, according to the company.