Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression endure extended periods trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when used alone, can begin to alleviate symptoms as soon as 24 hours after treatment and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike other antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the brain’s most abundant neurotransmitter, plays a crucial role in neuron communication.
Sales of Spravato surged 60% to $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.