Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 to be used alongside an oral antidepressant for patients whose depression symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who are affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release the struggles faced by patients dealing with difficult-to-treat depression, highlighting that many spend excessive time cycling through various treatments that fail to alleviate their symptoms, placing a considerable emotional and functional strain on both themselves and their families.
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when utilized as a standalone treatment, alleviated patient symptoms as early as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is administered through a nasal spray and must be taken under medical supervision in a healthcare facility. Unlike traditional antidepressants that influence brain chemicals such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the predominant neurotransmitter in the brain, crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million during the three months ending on June 30, compared to the same period in 2022. The drug has been utilized by approximately 100,000 individuals across 77 countries, according to the company.