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 hours1 SPRAVATO® alone showed a rapid ...

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.

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 ...

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 ...

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 ...

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 ...

Oct 24, 2024 · New five-year data reinforce long-term safety and efficacy of SPRAVATO® (esketamine) in patients with inadequate response to two or more oral antidepressants (treatment-resistant depression)

Jan 22, 2025 · Spravato is now the first stand-alone therapy for treatment-resistant depression, for patients who haven't responded to oral antidepressants.

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 ...

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.