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 medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially granted FDA approval in 2019 for use alongside an oral antidepressant for individuals whose symptoms had not improved after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally living with major depressive disorder suffer from 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 submission includes findings from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances levels of glutamate in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuron communication.
The sales of Spravato experienced a 60% increase, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been used by 100,000 people across 77 countries.