Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide who suffer from major depressive disorder have treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients with difficult-to-treat depression often endure prolonged periods trying various ineffective treatments, leading to significant emotional and functional challenges for both themselves and their families.
The application for expanded use was accompanied by data from a late-stage clinical trial, which indicated that Spravato, when administered alone, could alleviate symptoms as quickly as 24 hours after treatment and provide relief for at least 4 weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that typically focus on regulating neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing levels of glutamate, the most prevalent neurotransmitter in the brain, which plays a crucial role in neuronal communication.
Sales figures for Spravato showed a remarkable increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.