Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve with two or more other antidepressants.
According to Johnson & Johnson, around 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 application for the expanded usage was based on data from a late-stage clinical trial, indicating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours and provide relief for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that mainly affect serotonin and dopamine levels in the brain, Spravato enhances glutamate function. Glutamate is the most abundant neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reported that the drug has already been utilized by 100,000 patients across 77 countries.