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 ...
FDA approves standalone use of J&J’s ketamine-derived ... - CNN
5 days ago · The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
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 ...
SPRAVATO® (esketamine) approved in the U.S. as the first and …
6 days ago · This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO ® alone ...
Janssen Announces U.S. FDA Approval of SPRAVATO
Aug 3, 2020 · SPRAVATO ® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
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 allows standalone use of nasal spray antidepressant Spravato ...
5 days ago · The original approval required that patients on Spravato also receive an oral antidepressant. Now, the FDA says the drug can be used on its own. The decision came after a large study found that ...
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