SPRAVATO - Johnson & Johnson
Jan 21, 2025 · 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 compared to placebo as early as 24 hours 1
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 ...
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.
J&J shares data on would-be blockbuster antidepressant
4 days ago · Johnson & Johnson’s seltorexant is one of two new therapies that the company reckons could become blockbuster treatments for depression, and data from a phase 3 trial keeps that hope alive.
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 ...
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 ...
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 ...
J&J's drug eases depression and insomnia symptoms in late-stage …
May 29, 2024 · Johnson & Johnson's experimental drug helped reduce symptoms of depression as well as insomnia in patients with major depressive disorder (MDD) in a late-stage trial, the company said in...
Spravato Nasal Spray Can Now Be Used Alone for Treatment …
5 days ago · Last year, drugmaker Johnson & Johnson shared data from another clinical trial comparing Spravato as a standalone medication to a placebo for people with treatment-resistant depression. After four weeks, 22.5% of patients taking Spravato achieved remission based on a depression rating scale, compared to 7.6% of patients taking a placebo.
Major depression: FDA approves esketamine nasal spray
6 days ago · Mattingly has been involved with recent research and clinical trials regarding Spravato (esketamine) — a prescription nasal spray made by Johnson & Johnson (J&J) used to treat depression that ...