Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially intended for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more traditional antidepressants.
The company highlighted that nearly 30 percent of the approximately 280 million people worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face as they often cycle through numerous ineffective treatments, which can significantly affect both their quality of life and that of their loved ones.
The application to the FDA includes evidence from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment could alleviate symptoms in patients as quickly as 24 hours after administration and maintain those effects for a minimum of 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 conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato operates by increasing glutamate levels, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the second quarter compared to the same timeframe in the previous year. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.