Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato. The company seeks to have Spravato recognized as a standalone treatment for patients with treatment-resistant depression.
The FDA first authorized Spravato in 2019 for use alongside an oral antidepressant for individuals whose symptoms did not improve with two or more other antidepressants. According to Johnson & Johnson, approximately 30 percent of the 280 million individuals worldwide suffering from 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 to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, began alleviating patients’ symptoms within 24 hours and continued to do so for at least four weeks post-treatment.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato increases glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.