Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato. The company aims for it to be utilized as a standalone therapy for patients suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose depression did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the plight of these patients, stating that they often endure prolonged periods of ineffective treatments that place a significant emotional and functional burden on them and their loved ones.
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that patients treated with Spravato as a standalone solution experienced symptom relief as quickly as 24 hours following treatment, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional within a clinical setting. In contrast to conventional antidepressants that function by influencing serotonin and dopamine levels, Spravato operates by enhancing glutamate activity in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, 2023, compared to the previous year. Johnson & Johnson reported that around 100,000 individuals across 77 countries have used Spravato.