Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals globally suffering from major depressive disorder are facing treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, noted in a press release, “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 indicating that Spravato, as a standalone treatment, began alleviating symptoms as soon as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be used under the supervision of a healthcare provider. Unlike traditional antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, a crucial neurotransmitter for neuron communication.
Sales for Spravato saw a significant rise, increasing by 60% to $271 million in the quarter ending June 30 compared to the same period in the previous year. The drug has been utilized by over 100,000 individuals across 77 countries, according to Johnson & Johnson.