Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients who did not respond to two or more antidepressant treatments.
Johnson & Johnson stated that nearly 30 percent of the approximately 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients with hard-to-treat depression, noting that they often spend excessive time undergoing various ineffective treatments, resulting in a considerable emotional and functional burden on both themselves and their families.
The application is supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment began to alleviate symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in a clinical environment. Unlike typical antidepressants that adjust brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels, the most prevalent neurotransmitter in the brain, facilitating neuronal communication.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30 compared to the same period last year. The drug has been utilized by around 100,000 patients across 77 countries, according to the company.