Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug Spravato to be used as a standalone therapy for treatment-resistant depression.
The FDA first approved Spravato in 2019 to be used in combination with an oral antidepressant for patients whose symptoms did not improve with two or more antidepressants.
Approximately 30 percent of the estimated 280 million people worldwide living with major depressive disorder have treatment-resistant depression, according to Johnson & Johnson.
“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,” said Johnson & Johnson head of neuroscience Bill Martin in a press release.
The application was submitted with data from a late-stage clinical trial that showed Spravato, as a standalone treatment, helped ease patients’ symptoms as early as 24 hours after treatment and for at least 4 weeks of treatment.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a healthcare setting. Unlike other antidepressants that regulate chemicals like serotonin and dopamine in the brain, Spravato works by boosting glutamate in the brain. Glutamate is the most abundant neurotransmitter in the brain and helps neurons communicate with each other.
Sales of Spravato soared 60% to $271 million in the three months ended June 30, compared with the same period in 2023. Spravato has been used by 100,000 people in 77 countries, according to Johnson & Johnson.