SPRAVATO® (esketamine) approved in the U.S. as the first and …
Jan 21, 2025 · 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 and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical ...
Managing Depression With Spravato - WebMD
Spravato (esketamine) is a nasal spray used for depression and was approved by the FDA in 2019. It is specifically for treatment-resistant depression, meaning depression symptoms that have...
What to Know About the New Nasal Spray for Tough Depression
Jan 27, 2025 · 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 ...
Spravato Nasal Spray Can Now Be Used Alone for Treatment …
6 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.
SPRAVATO® (esketamine): A Prescription Nasal Spray | SPRAVATO…
SPRAVATO®, the only FDA-approved nasal spray for adults with treatment-resistant depression, reduces depression symptoms when two or more oral antidepressants haven't worked. SPRAVATO® can be taken with or without an oral antidepressant.
FDA approves new nasal spray medication for treatment-resistant ...
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other...
FDA Expands Approval of Intranasal Esketamine Therapy (Spravato)
Jan 22, 2025 · In a significant step forward for mental health care, the U.S. Food and Drug Administration (FDA) has expanded its approval of Spravato (esketamine) nasal spray. Initially approved in 2019 for treatment-resistant depression, Spravato is now cleared for use as a standalone treatment for major depressive disorder (MDD).
Janssen Announces U.S. FDA Approval of SPRAVATO
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.
Spravato Approved as Monotherapy for Treatment-Resistant Depression
Jan 21, 2025 · Spravato is also indicated for the treatment of depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant ...
Major depression: FDA approves esketamine nasal spray
Jan 27, 2025 · The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.