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 utilized as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, highlighting the prolonged cycle of ineffective treatments that can bring significant emotional and functional burdens to both patients and their families.
The application for expanded use was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms as quickly as 24 hours post-treatment and sustained benefits for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in a medical environment. Unlike conventional antidepressants that influence neurotransmitters such as serotonin and dopamine, Spravato enhances the action of glutamate, the most prevalent neurotransmitter in the brain, facilitating neuronal communication.
In terms of financial performance, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been accessed by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.