SPRAVATO® (esketamine) approved in the U.S. as the first and …
Jan 21, 2025 · You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO ® and discuss any questions you may have with your healthcare provider. cp-170363v4. ABOUT JOHNSON & JOHNSON
SPRAVATO® (esketamine) approved in the U.S. as the first and …
Jan 21, 2025 · SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2 ... Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with ...
FDA approves standalone use of J&J’s ketamine-derived depression ...
Jan 22, 2025 · 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 ...
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 ...
Johnson & Johnson ketamine-derived nasal spray gets FDA …
Jan 22, 2025 · On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray, Spravato (esketamine), to treat major depressive disorder. Oral antidepressants are the most common ...
FDA approves Johnson & Johnson nasal spray Spravato for depression
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 approves first-of-its-kind nasal spray for severe depression
Jan 22, 2025 · 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 Esketamine as First Monotherapy for Treatment …
Jan 21, 2025 · 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 ...
Johnson & Johnson Strengthens Neuroscience Leadership with …
Jan 13, 2025 · Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Acquisition includes CAPLYTA ® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA ® as adjunctive treatment for ...
Is this the end of one-size-fits-all treatments for depression?
Jan 23, 2024 · For World Mental Health Day, learn how Johnson & Johnson is working to bring personalized psychiatry to the 7 in 10 people with depression whose treatments aren’t getting the job done.