Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not benefit from two or more antidepressants, Spravato is now being proposed for independent use. According to Johnson & Johnson, nearly 30 percent of the approximate 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, noted in a press release that many patients with difficult-to-treat depression endure prolonged periods of cycling through ineffective treatments, which places significant emotional and functional stress on them and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato used alone can alleviate patients’ symptoms as early as 24 hours after administration and continues to be effective for at least 4 weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a crucial role in neuronal communication.
In the second quarter ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in 2022. Johnson & Johnson stated that the medication has been utilized by around 100,000 patients across 77 countries.