The FDA’s latest approval of the nasal spray Spravato (esketamine) CIII marks a major shift in how major depressive disorder is managed, allowing people who have tried at least two oral ...
Esketamine is the first monotherapy for MDD with inadequate response to two oral antidepressants, approved after a priority FDA review. Clinical trials showed esketamine's rapid efficacy, with 22. ...
The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. It was approved... The U.S. Food and Drug Administration has ...
The US Food and Drug Administration (FDA) has approved a supplemental new drug application allowing esketamine nasal spray (Spravato; Johnson & Johnson) to be used as a standalone treatment in ...
6 The mechanism by which esketamine exerts its antidepressant effect is unknown. Backed by more than a decade of research and almost six years of real-world evidence, SPRAVATO® has proven to be a ...
The US Food and Drug Administration (FDA) has approved the use of esketamine nasal spray as a standalone treatment for adults with major depressive disorder (MDD) who have not responded adequately ...
The drug is now cleared for use as a standalone treatment for depression. Spravato is made from esketamine, one of two mirror-image molecules found in the anesthetic ketamine. It was approved in ...