Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to update the approval of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first greenlit by the FDA in 2019 as an adjunct to traditional oral antidepressants for patients whose symptoms showed no improvement after trying two or more different medications.
According to Johnson & Johnson, nearly 30% of the approximately 280 million people worldwide who suffer from 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, noting that many often endure prolonged cycles of ineffective treatments, leading to considerable emotional and functional distress for both patients and their families.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was able to alleviate patients’ symptoms within 24 hours of treatment and sustained this effect for at least four weeks.
Spravato is administered via nasal spray and requires supervision by a healthcare professional in a clinical setting. In contrast to conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the brain’s most prevalent neurotransmitter and is vital for neuron communication.
Sales of Spravato rose by 60% to $271 million in the quarter ending June 30 compared to the same period in 2022. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.