Johnson & Johnson announced on Monday that it has filed for approval from the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato received its initial FDA approval in 2019, but it was only allowed for use in conjunction with an oral antidepressant for those who did not see improvements after trying two or more such medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggling with difficult-to-treat depression often spend excessive amounts of time cycling through ineffective treatments, which can impose a significant emotional and functional strain on them and their families.
The recent application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, showed a reduction in patient symptoms within as little as 24 hours and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the observation of a healthcare professional in a medical setting. Unlike traditional antidepressants that modulate neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. According to the company, the treatment has been utilized by 100,000 individuals across 77 countries.