Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, noting that they often endure prolonged periods of trying multiple ineffective treatments, which can impose a substantial emotional and functional burden on both patients and their families.
The new application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, began alleviating patient symptoms as quickly as 24 hours post-treatment and continued to provide relief 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 clinical setting. Unlike traditional antidepressants that focus on regulating neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, a neurotransmitter vital for effective neuron communication.
Sales for Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.