Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve with two or more other antidepressants.
Johnson & Johnson indicated that nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at 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 was accompanied by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated symptoms in patients as early as 24 hours after treatment and continued to show effectiveness for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider within a healthcare setting. Unlike traditional antidepressants that typically regulate brain chemicals such as serotonin and dopamine, Spravato functions by enhancing the activity of glutamate, the brain’s most abundant neurotransmitter, which aids in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.