Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to extend the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as part of a combination therapy alongside an oral antidepressant for patients whose conditions did not improve after trialing two or more other antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients struggling with difficult-to-treat depression often face prolonged periods of ineffective treatment, resulting in significant emotional and functional burdens for themselves and their families.
The application to the FDA includes findings from a late-stage clinical trial indicating that when used alone, Spravato can alleviate symptoms in patients as soon as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered in a healthcare setting under the supervision of a healthcare provider. Unlike other antidepressants that typically target serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is essential for neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in the previous year. According to Johnson & Johnson, the drug has been utilized by around 100,000 individuals across 77 countries.