Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based drug, Spravato, to function as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially, the FDA sanctioned Spravato in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, which places a substantial emotional and functional burden on both the patients and their families.
The application was accompanied by data from a late-stage clinical trial revealing that Spravato, when used as a standalone treatment, significantly alleviated patients’ symptoms as early as 24 hours post-treatment and sustained relief for at least four weeks.
Spravato is administered through a nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In the second quarter of 2023, sales of Spravato experienced a remarkable 60% increase, reaching $271 million compared to the same period last year. Johnson & Johnson reports that approximately 100,000 individuals in 77 countries have utilized Spravato.