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 drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who showed little improvement after trying two or more antidepressants.
Johnson & Johnson stated that nearly 30 percent of the approximately 280 million individuals worldwide affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients dealing with difficult-to-treat depression, noting that they often spend excessive time trying various treatments that fail to alleviate their symptoms. This situation can lead to significant emotional and functional challenges for both patients and their families.
The application to the FDA includes results from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours after administration and maintain its effects for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that primarily influence neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato saw a 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by around 100,000 patients across 77 countries, according to Johnson & Johnson.