Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally with major depressive disorder suffer from treatment-resistant depression.
“Many patients with difficult-to-treat depression often spend excessive time cycling through various treatments that fail to alleviate their symptoms, resulting in significant functional and emotional strain on both the patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, can begin to alleviate symptoms in patients as quickly as 24 hours post-treatment and can continue to do so for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that modulate chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In recent financial results, Spravato sales surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.