Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients who had not responded to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximate 280 million people suffering from major depressive disorder globally experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the prolonged struggles many patients face while trying various ineffective treatments, noting the significant functional and emotional toll this can take on both patients and their families.
The application for expanded use was backed by data from a late-stage clinical trial, which indicated that Spravato, when used alone, alleviated symptoms in patients as soon as 24 hours after administration and sustained these effects for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a professional setting. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating neuron communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as per Johnson & Johnson’s reports.