Core Viewpoint - Johnson & Johnson's Spravato (esketamine) has received FDA approval as a monotherapy for adults with treatment-resistant depression (TRD), marking it as the first and only treatment of its kind for this patient group [1][2]. Group 1: FDA Approval and Study Results - The FDA's approval was based on a double-blind, multicenter, placebo-controlled study demonstrating that Spravato alone led to rapid and superior improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to placebo [3]. - Treatment with Spravato alone showed significant improvement in depressive symptoms as early as 24 hours and met the primary endpoint at 4 weeks [4]. Group 2: Market Impact and Sales Performance - In the first nine months of 2024, Spravato generated sales of $780 million, reflecting a year-over-year increase of 61.5%, driven by heightened physician and patient demand [5]. - The approval for Spravato as a standalone treatment is expected to further enhance its sales in upcoming quarters [5]. Group 3: Stock Performance - Over the past year, Johnson & Johnson's shares have decreased by 7.3%, while the industry has seen a decline of 5.1% [2].
J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use