SPRAVATO® (esketamine) approved in the U.S. as the first and …
Jan 21, 2025 · 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 ...
Spravato Nasal Spray Can Now Be Used Alone for Treatment …
10 hours ago · The Food and Drug Administration (FDA) has expanded its approval of a ketamine nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment-resistant depression. Spravato was first approved for use in 2019 to treat people with major depressive disorder who did not respond to ...
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...
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
6 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 Approves Spravato Nasal Spray for Treatment-Resistant …
Jan 22, 2025 · 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 approves Johnson & Johnson nasal spray Spravato for …
Jan 21, 2025 · Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
FDA allows standalone use of nasal spray antidepressant Spravato ...
Jan 21, 2025 · 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 Expands Approval of Intranasal Esketamine Therapy (Spravato)
Jan 22, 2025 · 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 ...
Consider the risks and benefits of prescribing SPRAVATO prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse. Increased risk of suicidal...