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 drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato received FDA approval in 2019 as an adjunct to an oral antidepressant for patients who had not responded to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, who often endure prolonged periods of ineffective treatments that adversely affect their emotional and functional well-being.
The submission to the FDA includes data from a late-stage clinical trial indicating that Spravato as a standalone treatment can alleviate symptoms within 24 hours and sustain improvements for at least four weeks.
Administered as a nasal spray, Spravato requires administration under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuronal communication.
In terms of sales, Spravato experienced a significant increase, with a 60% rise to $271 million in the quarter ending June 30, compared to the same period in 2023. According to the company, Spravato has been utilized by 100,000 people across 77 countries.