Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Previously, the FDA approved Spravato in 2019 to be used alongside an oral antidepressant for patients who did not see significant improvement with two or more other antidepressants.
Johnson & Johnson noted that approximately 30 percent of the estimated 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
“Many patients with difficult-to-treat depression spend too much time trying various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional burdens for them and their loved ones,” said Bill Martin, Johnson & Johnson’s head of neuroscience, in a press release.
The application includes data from a late-stage clinical trial demonstrating that Spravato, as a standalone treatment, alleviated patients’ symptoms within 24 hours and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be used under healthcare provider supervision in a medical setting. Unlike other antidepressants that adjust chemicals such as serotonin and dopamine in the brain, Spravato increases glutamate levels, which is the most abundant neurotransmitter in the brain and aids neuron communication.
Spravato sales surged 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, 100,000 people across 77 countries have used Spravato.