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 drug, Spravato. The company aims for Spravato to be recognized as a standalone therapy for individuals suffering from treatment-resistant depression.
Spravato received its initial FDA approval in 2019, allowing its use alongside an oral antidepressant for patients whose symptoms did not improve with two or more other antidepressants.
Johnson & Johnson highlighted that nearly 30% of the 280 million individuals globally living with major depressive disorder have treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause significant functional and emotional burdens on patients and their loved ones.”
The application for expanded approval includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms for patients as quickly as 24 hours after treatment and sustained this improvement for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare provider in a designated healthcare setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is crucial for neuronal communication.
In terms of sales, Spravato experienced a 60% increase, generating $271 million in the three months ending June 30, compared to the same period last year. The drug has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.