Johnson & Johnson announced on Monday that it has officially submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be administered alongside an oral antidepressant for patients who had not seen improvements after trying two or more antidepressant treatments. Johnson & Johnson emphasizes the need for this application, noting that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed the urgency of this initiative, stating that many patients endure lengthy cycles of ineffective treatments, resulting in significant emotional and functional challenges for both themselves and their families.
The application to the FDA was bolstered by data from a late-stage clinical trial indicating that patients using Spravato as a standalone treatment experienced relief from symptoms as quickly as 24 hours after administration, with benefits lasting at least four weeks. Spravato is delivered in the form of a nasal spray and requires supervision by a healthcare professional during its administration. Unlike typical antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, facilitating better neuron communication.
Sales for Spravato have significantly risen, with a remarkable increase of 60% to $271 million in just three months ending June 30 compared to the previous year. The treatment has already benefitted approximately 100,000 patients across 77 countries.
This development reflects a hopeful advancement in mental health treatment, particularly for those who have faced frustration and despair from conventional therapies. The potential for Spravato as a standalone solution could bring renewed hope to many struggling with this debilitating condition.
In summary, Johnson & Johnson’s push for FDA approval to use Spravato as an independent treatment for resistant depression highlights the ongoing commitment to providing effective solutions for individuals grappling with severe mental health challenges. The promising results from clinical trials further enhance optimism for those seeking relief from their symptoms.