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 used as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with oral antidepressants for patients who had not seen improvements after trying two or more such medications.
The company noted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges these patients face, stating that many struggle with ineffective treatments for extended periods, which can create significant emotional and functional challenges for them and their families.
The application includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms within 24 hours of treatment and maintain such effects for at least four weeks.
Spravato is administered through a nasal spray and must be taken under healthcare supervision. Unlike typical antidepressants that target brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In related news, Spravato’s sales surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.