Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more other antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the significant challenges these patients face, often spending extended periods trying ineffective treatments, which can place a heavy burden on both them and their families.
The recent application includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours of administration and provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Differing from traditional antidepressants that primarily target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. The medication has been utilized by approximately 100,000 patients across 77 countries.