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, for treatment-resistant depression as a standalone therapy.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder suffer from treatment-resistant depression.
“Many patients with difficult-to-treat depression often take too long to cycle through various treatments that fail to alleviate their symptoms, leading to substantial 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 to the FDA includes data from a late-stage clinical trial showing that Spravato, when used alone, can alleviate symptoms for patients as quickly as 24 hours after treatment and maintain its effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider. Unlike conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales of Spravato surged by 60% to $271 million in the second quarter compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.