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 used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use alongside an oral antidepressant for patients whose conditions did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the plight of patients struggling with difficult-to-treat depression, highlighting the prolonged periods they often endure while trying multiple ineffective treatments, which can lead to significant emotional and functional challenges for both the patients and their families.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was able to alleviate patients’ symptoms as quickly as 24 hours after the treatment and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine in the brain, Spravato enhances levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2022. The medication has already been utilized by 100,000 patients across 77 countries, according to the company.