Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication Spravato, allowing it to be utilized as a standalone treatment for resistant depression.
Spravato was first authorized by the FDA in 2019 as a complementary therapy alongside oral antidepressants for patients whose depression did not respond to two or more such medications. The company highlighted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder face treatment-resistant depression.
“The burden of untreated depression can be significant, affecting not just the patient but also their loved ones. Patients often endure lengthy cycles of various treatments that fail to alleviate their symptoms,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission to the FDA included findings from a late-stage clinical trial indicating that Spravato, when used alone, can reduce symptoms within 24 hours of administration and maintain effectiveness 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 setting. Unlike traditional antidepressants that modify levels of neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is essential for neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period the previous year. The medication has been dispensed to 100,000 individuals across 77 countries, according to Johnson & Johnson.