Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) seeking to extend the approved use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
The FDA initially granted approval for Spravato in 2019, allowing its use alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the 280 million people worldwide dealing with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients with hard-to-treat depression, noting that they often endure prolonged periods trying various ineffective treatments, leading to significant emotional and functional burdens for both patients and their families.
The application to the FDA was accompanied by findings from a late-stage clinical trial, which indicated that Spravato, when used alone, demonstrated the ability to alleviate symptoms within 24 hours and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuronal communication.
Sales of Spravato have surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by 100,000 individuals across 77 countries, according to the company.