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, to be utilized as a standalone treatment for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing it to be prescribed in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that 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, expressed 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,” noting the significant emotional and functional burden this places on both patients and their families.
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when administered alone, significantly alleviated symptoms in patients as soon as 24 hours post-treatment, with effects lasting at least four weeks.
Spravato is delivered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical environment. In contrast to traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a crucial role in enabling communication between neurons.
Sales of Spravato experienced a 60% increase, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the treatment has been used by 100,000 patients across 77 countries.