Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 as an adjunct to an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications. Johnson & Johnson noted that nearly 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, expressed in a press release that many patients with difficult-to-treat depression often endure prolonged periods of ineffective treatments, which can lead to considerable emotional and functional challenges for both patients and their families.
The application includes data from a recent late-stage clinical trial indicating that Spravato, when used alone, has the potential to alleviate symptoms within 24 hours and is effective for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional in a clinical environment. Unlike typical antidepressants that modify serotonin and dopamine levels, Spravato operates by enhancing glutamate activity in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales of Spravato experienced a significant 60% increase, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.