Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato initially received FDA approval in 2019, but only for use alongside an oral antidepressant for patients who have not seen improvement after trying two or more antidepressants.
The pharmaceutical company noted that nearly 30 percent of the 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release that patients dealing with difficult-to-treat depression often spend too long cycling through various ineffective treatments, leading to significant emotional and functional challenges for both them and their families.
The application submitted to the FDA includes data from a late-stage clinical trial, which demonstrated that Spravato, when used alone, could help alleviate symptoms in patients as quickly as 24 hours after treatment and for up to four weeks afterwards.
Spravato is administered as a nasal spray and must be taken in a supervised healthcare environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate in the brain, which plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.