Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the authorized use of its ketamine-derived drug Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was originally indicated for use in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressant medications.
Johnson & Johnson estimates that around 30 percent of the 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, remarked in a press release, “Many patients experiencing difficult-to-manage depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, which can create a significant emotional and functional toll on them and their families.”
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, could alleviate symptoms as early as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional within a clinical setting. Unlike other antidepressants that focus on regulating brain chemicals such as serotonin and dopamine, Spravato increases glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, approximately 100,000 individuals in 77 countries have utilized Spravato.