Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. Johnson & Johnson stated that approximately 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles of patients dealing with difficult-to-treat depression, noting that they often endure prolonged periods trying multiple ineffective treatments, which can lead to significant emotional and functional challenges for both them and their families.
The application includes findings from a late-stage clinical trial, which revealed that Spravato, when used alone, could alleviate symptoms in patients as soon as 24 hours after administration, and these benefits lasted for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato acts by increasing levels of glutamate in the brain, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30 compared to the same period last year. The medication has been utilized by around 100,000 patients in 77 countries, as reported by Johnson & Johnson.