Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-derived drug, Spravato, allowing it to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Originally approved in 2019, Spravato was designed for use alongside an oral antidepressant for patients who had not seen improvement after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
“Numerous patients dealing with difficult-to-treat depression often endure lengthy cycles of ineffective treatments, inflicting considerable functional and emotional strain on them and their families,” commented Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The recent application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours after administration and sustained relief for a minimum of four weeks.
Spravato is delivered through a nasal spray, necessitating administration under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants, which target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain—a vital neurotransmitter that facilitates communication between neurons.
Sales of Spravato experienced a substantial increase of 60%, reaching $271 million during the three months ending June 30, compared to the same timeframe in 2022. Johnson & Johnson noted that the medication has been used by 100,000 individuals across 77 countries.