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-based medication, Spravato, to serve as a standalone treatment for individuals with treatment-resistant depression.
The FDA first approved Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose symptoms did not improve with two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people suffering from major depressive disorder worldwide experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients with hard-to-treat depression, noting that they often endure extended periods switching between ineffective treatments, which places a considerable emotional and functional strain on them and their families.
The submission was backed by data from a late-stage clinical trial, which indicated that Spravato, when used alone, could alleviate symptoms in patients as soon as 24 hours post-treatment and maintain relief for at least four weeks.
Spravato is administered via nasal spray and is required to be taken under the supervision of a healthcare professional in a clinical setting. Unlike typical antidepressants, which target brain chemicals such as serotonin and dopamine, Spravato raises levels of glutamate, the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato experienced a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.