Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially authorized Spravato in 2019 for use in conjunction with an oral antidepressant for patients who had not experienced improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder live with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated 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 backed by data from a late-stage clinical trial which demonstrated that Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained this relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that mainly target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales for Spravato saw a significant increase of 60%, totaling $271 million in the quarter ending June 30 compared to the same period in 2022. According to the company, Spravato has been used by around 100,000 individuals across 77 countries.