Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for those with treatment-resistant depression.
Spravato received FDA approval in 2019, originally intended for use in conjunction with an oral antidepressant for patients who did not respond to at least two other antidepressant medications.
According to Johnson & Johnson, approximately 30 percent of the 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Patients suffering from difficult-to-treat depression often spend too long 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 demonstrating that Spravato, when used as a standalone treatment, provided symptom relief within 24 hours of administration and continued to be effective for at least four weeks.
Spravato, which is delivered as a nasal spray, must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that typically influence neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the medication has been used by 100,000 individuals across 77 countries.