Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval to use its ketamine-based medication, Spravato, as a standalone treatment for adults with treatment-resistant depression.
Spravato, which the FDA first approved in 2019, was originally intended to be used alongside an oral antidepressant for patients whose symptoms remained unresolved after trying two or more antidepressants.
The pharmaceutical company noted that nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated that patients facing difficult-to-treat depression often endure extensive periods trying various treatments that fail to alleviate their symptoms, leading to considerable emotional and functional challenges for both patients and their families.
The application to the FDA includes data from a late-stage clinical trial, which indicated that Spravato, used alone, significantly alleviated symptoms for patients within 24 hours and maintained this effect for at least four weeks.
Spravato is administered via a nasal spray and is required to be given under the supervision of a healthcare provider in a designated healthcare setting. Differently from conventional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the predominant neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same period in 2022. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.