Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-derived medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato initially received FDA approval in 2019 for use alongside an oral antidepressant for those whose depression did not improve with two or more other antidepressants. Johnson & Johnson noted that 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 the difficulties faced by patients with hard-to-treat depression, stating that many endure prolonged periods of trying various ineffective treatments, which can impose significant emotional and functional stress on both patients and their families.
The application for expanded use is supported by data from a late-stage clinical trial showing that Spravato, when used alone, can alleviate symptoms in patients as quickly as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare environment under professional supervision. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been used by approximately 100,000 patients across 77 countries.