Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially sanctioned for use alongside an oral antidepressant for individuals whose symptoms failed to improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30% of the approximately 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that patients dealing with difficult-to-treat depression often endure lengthy periods trying various treatments that do not effectively alleviate their symptoms, which can impose significant functional and emotional challenges on them and their families.
The filing was backed by data from a late-stage clinical study indicating that Spravato, when used as a standalone treatment, was able to alleviate symptoms within 24 hours of administration and maintained efficacy for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, playing a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.