Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-derived medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions failed to improve after two or more antidepressants. The company noted that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients who often go through numerous ineffective treatments, which can impose a significant emotional and functional burden on them and their families.
The application for expanded use was backed by results from a late-stage clinical trial showing that Spravato, when used alone, could alleviate symptoms in patients as quickly as 24 hours after administration, with benefits lasting 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 environment. Unlike traditional antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain, a critical neurotransmitter for neuron communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.