Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the expansion of its ketamine-based drug Spravato, seeking approval for its use as a standalone therapy for treatment-resistant depression.
Spravato, which previously received FDA approval in 2019, was initially authorized to be used in conjunction with an oral antidepressant for patients who had not seen improvements after trying two or more antidepressant treatments.
According to Johnson & Johnson, approximately 30% of the 280 million people worldwide living with major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggling with difficult-to-treat depression often endure prolonged periods trying multiple treatments that fail to alleviate their symptoms, placing a significant emotional and functional burden on them and their families.
The company’s application includes findings from a late-stage clinical trial demonstrating that Spravato, when used alone, can relieve patients’ symptoms within 24 hours of treatment and maintain effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressant medications, which typically target neurotransmitters such as serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, the most abundant neurotransmitter that facilitates neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30 compared to the same period in the previous year. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.