Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more other antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide 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 living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can impose a significant functional and emotional burden on patients and their loved ones.”
The application was supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, alleviating patients’ symptoms as early as 24 hours after administration and maintaining efficacy for at least four weeks.
Spravato is provided as a nasal spray, administered under the oversight of a healthcare provider within a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales for Spravato surged by 60% to $271 million in the three months leading up to June 30, compared to the same quarter the previous year. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.