Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, to allow it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that they often undergo numerous ineffective treatments, which can lead to significant emotional and functional burdens on them and their families.
The application submitted to the FDA included data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike typical antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing the activity of glutamate, the most prevalent neurotransmitter, 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 2023. According to Johnson & Johnson, Spravato has been utilized by approximately 100,000 patients across 77 countries.