Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived drug, Spravato, allowing it to be utilized as a solo treatment for individuals with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more other antidepressants.
The company highlighted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients with hard-to-treat depression endure prolonged periods cycling through multiple therapies that fail to alleviate their symptoms, leading to considerable functional and emotional challenges for both themselves and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press statement.
The submission was supported by results from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms within 24 hours and maintain efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under medical supervision in a healthcare facility. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.