Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
The FDA first gave its approval to Spravato in 2019, allowing it to be used alongside an oral antidepressant for patients whose symptoms remained unaddressed after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
“Many patients living with difficult-to-treat depression endure lengthy periods trying numerous treatments that fail to effectively alleviate their symptoms, which can lead to significant functional and emotional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was backed by data from a late-stage clinical trial indicating that Spravato, when used alone, can reduce symptoms within 24 hours of treatment 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 professional in a clinical setting. Unlike traditional antidepressants that alter neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same time frame in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.