Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
First approved by the FDA in 2019, Spravato was initially authorized for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression. The company’s head of neuroscience, Bill Martin, noted that many patients dealing with hard-to-treat depression often go through numerous ineffective treatments, creating significant emotional and functional challenges for them and their families.
The application for the new use of Spravato is backed by data from a late-stage clinical trial indicating that the medication can alleviate symptoms as soon as 24 hours post-treatment and continue to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under medical supervision in a healthcare facility. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is critical for neuron communication.
In recent financial results, sales of Spravato increased by 60%, reaching $271 million for the three months ending June 30, compared to the same period in 2022. The drug has already been utilized by 100,000 patients across 77 countries, according to the company.