Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approval of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide who experience major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application was supported by data from a late-stage clinical trial, which showed that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours after treatment and sustained improvement for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Differing from other antidepressants that adjust chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a critical role in neuron communication.
Sales of Spravato grew by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.