Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, enabling it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato is recommended to be used alongside an oral antidepressant for patients whose conditions do not improve with two or more previous antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that “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 expanded use is supported by data from a late-stage clinical trial which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained this effect 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. Differing from other antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances the function of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.