Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Since its initial approval in 2019, Spravato has been available only in combination with an oral antidepressant, specifically for patients whose symptoms did not improve after undergoing treatment with two or more antidepressants.
Currently, nearly 30 percent of the approximately 280 million people worldwide diagnosed with major depressive disorder are believed to suffer from treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the struggles faced by many patients dealing with difficult-to-treat depression, noting that they often spend excessive time trying numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The company submitted its application based on findings from a late-stage clinical trial, which indicated that Spravato, when administered alone, could significantly alleviate symptoms within just 24 hours of treatment and maintain these effects for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that typically influence neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same timeframe in the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.