Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a supplementary treatment alongside an oral antidepressant for patients who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, stating that they often spend too long trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional strain on both patients and their families.
The application submitted to the FDA includes data from a late-stage clinical trial indicating that Spravato, when administered as a standalone treatment, showed improvement in patients’ symptoms as quickly as 24 hours after treatment and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike conventional antidepressants that alter neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate, the brain’s most abundant neurotransmitter, is crucial for communication between neurons.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.