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

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 · 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 ...

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 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 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 ...

Jan 21, 2025 · 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.

Jan 21, 2025 · Spravato ® (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression. News release. Johnson & Johnson. January 21, 2025.

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.

Jan 22, 2025 · An emerging treatment for clinical depression has reached an important milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato ...