Jan 21, 2025 · Titusville, New Jersey, January 21, 2025 – Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO ® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to ...

Aug 3, 2020 · SPRAVATO ® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

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.

Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression

Jan 21 (Reuters) - The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's (JNJ.N), opens new tab nasal spray, Spravato, to allow it to be used as a standalone treatment ...

Jan 22, 2025 · At the end of week four of the trial, just 7.6-percent of the placebo group reported a MADRS score indicating remission, compared to 22.5-percent of those taking Spravato. According to Johnson ...

5 days ago · A study by Johnson & Johnson, the company that makes Spravato, showed that 22.5% of people using esketamine nasal spray achieved remission from major depression in four weeks. Just 7.6% of people ...

Jan 22, 2025 · Spravato, which is derived from ketamine, is not a new drug—it first came on the market in 2019. The spray was previously approved as a companion treatment to an oral antidepressant, as well as ...

4 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.

Jan 21, 2025 · The FDA has approved esketamine (Spravato) for the treatment of major depressive disorder (MDD) in adult patients who have had inadequate response to at least 2 oral antidepressants, Johnson and Johnson announced in a release. 1 The decision makes Spravato the first and only monotherapy approved for adults living with the condition.