Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato. The company seeks to have Spravato recognized as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019, intended for use in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience for Johnson & Johnson, stated, “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 for the new indication is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms in patients as early as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. In contrast to traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, which is the brain’s most abundant neurotransmitter and vital for neuron communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.