Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in conjunction with an oral antidepressant for patients who have not observed improvements after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients grappling with difficult-to-treat depression find themselves spending excessive time cycling through various treatments that fail to alleviate their symptoms, resulting in considerable functional and emotional strain on both patients and their families,” stated 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 that demonstrated Spravato’s effectiveness as a standalone treatment, with symptom relief reported as soon as 24 hours after administration and lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a suitable clinical environment. Unlike other antidepressants that target brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter responsible for neuron communication.
Sales of Spravato jumped 60% to $271 million in the three months ending June 30 when compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.