Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant, targeting patients whose conditions did not improve after trying two or more antidepressant medications. Johnson & Johnson noted that nearly 30% of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients with hard-to-treat depression, stating that many endure prolonged struggles with various treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens for both themselves and their families.
The submission to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours of administration and maintain this effect for at least four weeks.
Spravato is delivered via a nasal spray and must be administered in a healthcare setting under the supervision of a healthcare professional. Unlike conventional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023, compared to the same period last year. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.