The FDA has approved Johnson & Johnson's Spravato (esketamine) nasal spray for the treatment of adults with treatment-resistant depression (TRD).

Johnson & Johnson (JNJ.US) announced on January 21 that the US FDA has approved its Spravato (esketamine) nasal spray for the treatment of treatment-resistant depression (TRD) in adult patients. Trial results show that Spravato reached the primary endpoint at week 4. Additionally, compared to placebo, it rapidly and significantly improved depressive symptoms in patients within 24 hours. According to the press release, Spravato is the first monotherapy approved to treat adult patients with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. Currently, approximately 1 in 8 people worldwide suffer from mental illness. Depression is one of the most common mental illnesses, affecting around 280 million people globally. Meanwhile, nearly two-thirds of depression patients do not achieve adequate relief from current treatments. When patients with severe depression do not respond to two or more treatment methods, they may progress to treatment-resistant depression, creating a significant need for new treatment options. The approval was based on positive results from a randomized, double-blind, multicenter, placebo-controlled study. Analysis shows that Spravato monotherapy demonstrated rapid and significant efficacy compared to placebo in improving the total score on the Montgomery-sberg Depression Rating Scale (MADRS). By day 28, Spravato showed numeric improvement in all 10 MADRS items. At week 4, 7.6% of the placebo group and 22.5% of the Spravato group achieved remission (MADRS total score 12). Previous trial results also indicate that patients experienced rapid improvement in the MADRS total score within 24 hours of their first treatment with Spravato, with this change persisting for at least 4 weeks. Spravato nasal spray is a non-selective, non-competitive NMDA receptor antagonist that may help restore neural connections in the brains of patients with depression.