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 therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
Approximately 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
“Numerous patients facing difficult-to-treat depression often endure lengthy periods trying various treatments that fail to alleviate their symptoms, resulting in a considerable functional and emotional toll on both them and their families,” stated Bill Martin, Johnson & Johnson’s head of neuroscience, in a press release.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, showed symptom relief in patients as quickly as 24 hours after treatment and continued to demonstrate efficacy for at least four weeks.
Spravato is administered through a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. In contrast to traditional antidepressants that influence brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
During the three-month period ending June 30, sales of Spravato surged by 60%, reaching $271 million, compared to the same quarter in 2023. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.