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 drug, Spravato, as a stand-alone treatment for patients with treatment-resistant depression.
Approved by the FDA in 2019, Spravato was originally indicated to be used alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more traditional antidepressants.
According to Johnson & Johnson, approximately 30 percent of the 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 submitted includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as early as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato operates by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
In terms of sales, Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Over 100,000 people across 77 countries have utilized the Spravato treatment, according to Johnson & Johnson.