Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approval of its ketamine-based medication, Spravato, for use as a standalone therapy in treating resistant depression.
Initially approved in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for those patients whose depression symptoms did not improve after trying two or more antidepressant medications.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 struggling with hard-to-treat depression, stating that they often go through numerous treatments without finding relief, imposing considerable emotional and functional burdens on both themselves and their families.
The new application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated symptoms for patients as quickly as 24 hours after treatment and provided relief for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.