Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was indicated for use in conjunction with an oral antidepressant for patients whose symptoms continued despite trying two or more antidepressant medications.
The company stated that nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients enduring difficult-to-treat depression often face extended periods cycling through various treatments that fail to alleviate their symptoms. This situation can lead to significant emotional and functional burdens for both patients and their families.
The FDA application includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, was effective in alleviating patients’ symptoms as quickly as 24 hours post-treatment and maintained efficacy for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the brain’s predominant neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a notable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in the previous year. Johnson & Johnson reports that approximately 100,000 patients have utilized Spravato across 77 countries.