SPRAVATO - Johnson & Johnson
2 days ago · SPRAVATO ® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression 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 …
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and ...
FDA approves Johnson & Johnson’s nasal spray for depression …
The Food and Drug Administration approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow. The ...
J&J's ketamine-derived nasal spray approved by FDA to treat depression
1 day ago · The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression. Spravato, approved as a ...
FDA Approves Johnson & Johnson's Spravato as Standalone …
2 days ago · The Food and Drug Administration has approved Johnson & Johnson's nasal spray Spravato (esketamine) as a standalone treatment for adults with treatment-resistant depression. This landmark decision makes Spravato the first-ever monotherapy of its kind, offering hope for individuals who have not responded to at least two standard antidepressant therapies.
FDA approves standalone use of J&J’s ketamine-derived depression ...
1 day 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 Johnson & Johnson’s ketamine-derived nasal …
19 hours ago · FDA approves Johnson & Johnson’s ketamine-derived nasal spray for depression as standalone treatment BY Beth Greenfield An estimated 21 million American adults suffer from clinical depression.
FDA approves Spravato, first monotherapy nasal spray to treat depression
2 days ago · The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive ...
Johnson & Johnson pivotal study of seltorexant shows …
Titusville, New Jersey (May 29, 2024) – Johnson & Johnson announced today positive topline results from the pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms ...
J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy …
1 day ago · The FDA approves Johnson & Johnson's sNDA for Spravato as a monotherapy for adults with treatment-resistant depression.