Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Initially approved in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients who did not experience improvement with two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 recent application is based on findings from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with improvements in patients’ symptoms occurring as early as 24 hours post-treatment and lasting for at least four weeks.
Spravato is delivered via nasal spray and must be administered by a healthcare provider in a medical setting. Unlike traditional antidepressants that primarily act on neurotransmitters like serotonin and dopamine, Spravato enhances the function of glutamate, the most prevalent neurotransmitter in the brain that facilitates communication between neurons.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.