Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder are affected by treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles many patients face, noting that they often endure extended periods trying various treatments that fail to alleviate their symptoms, which places a considerable emotional and functional strain on themselves and their families.
The FDA application included findings from a late-stage clinical trial revealing that Spravato, when used as a standalone treatment, provided relief from symptoms as soon as 24 hours post-treatment and maintained improvement for at least four weeks.
Administered as a nasal spray, Spravato must be given under the supervision of a healthcare professional in a designated healthcare environment. Unlike other antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter aiding neuron communication.
Sales of Spravato surged by 60% to $271 million in the second quarter ending June 30, compared to the same quarter in 2023. The medication has been utilized by around 100,000 individuals across 77 countries, as reported by Johnson & Johnson.