SPRAVATO® (esketamine) approved in the U.S. as the first and …
5 days ago · Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours1 SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical ...
FDA approves new nasal spray medication for treatment-resistant ...
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried...
FDA approves Johnson & Johnson nasal spray Spravato for …
5 days ago · Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
4 days ago · Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was based on the results of a ...
SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant...
FDA allows standalone use of nasal spray antidepressant Spravato ...
5 days ago · The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. ... Spravato is intended to be administered under the direct ...
FDA approves first-of-its-kind nasal spray for severe depression
5 days ago · The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
5 days ago · Approval of Spravato, granted following FDA priority review, was based on the results of a randomized, double-blind, multicenter, placebo-controlled trial. On day 28 of the trial, patients taking Spravato exhibited numerical improvements for all 10 items on the Montgomery-Asberg Depression Rating Scale (MADRS). After four weeks, 22.5 percent of ...
FDA Expands Approval of Intranasal Esketamine Therapy (Spravato)
5 days ago · The FDA’s decision to approve Spravato for standalone use represents a beacon of hope for these individuals, offering a faster-acting, innovative treatment option. As the understanding of mental health continues to evolve, so too does the arsenal of treatments available to those in need. With the expanded approval of Spravato, the future ...
FDA Approves Esketamine as First Monotherapy for Treatment …
6 days ago · The US Food and Drug Administration (FDA) approved esketamine (SPRAVATO) CIII nasal spray as the first monotherapy for adults with treatment-resistant depression (TRD), announced by Johnson & Johnson on January 21, 2025. 1. The approval of this supplemental New Drug Application (sNDA) was based on phase 4 randomized, double-blind, multicenter, placebo-controlled study in which esketamine alone ...