Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approval for its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for those suffering from treatment-resistant depression.
Spravato received FDA approval in 2019, initially intended to be used in conjunction with an oral antidepressant for patients whose symptoms persisted despite trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide with major depressive disorder face treatment-resistant depression.
“Many patients experiencing difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, leading to considerable emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated symptoms for patients as quickly as 24 hours post-treatment and maintained improvements for at least four weeks.
Spravato is administered via nasal spray and is required to be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels, which is the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
In terms of sales performance, Spravato’s revenue jumped by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has been used by around 100,000 individuals across 77 countries, according to the company.