Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based drug, Spravato, allowing it to be used 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 undergoing treatment with two or more different antidepressants.
The company highlighted that nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder suffer from treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, expressed concern for patients facing this issue, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, could alleviate patients’ symptoms as quickly as 24 hours after treatment and maintain effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period last year. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.