Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. According to the company, nearly 30 percent of the approximately 280 million people globally living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed the challenges faced by patients dealing with hard-to-treat depression, highlighting the emotional and functional burdens these individuals and their families endure due to prolonged ineffective treatments.
The application to the FDA includes data from a recent late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms in patients as quickly as 24 hours after treatment and can be effective for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato operates by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter responsible for neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.