Posted by Michael Wonder on 17 Aug 2016
Esketamine receives breakthrough therapy designation from U.S. Food and Drug Administration for major depressive disorder with imminent risk for suicide
16 August 2016 - FDA action marks second breakthrough therapy designation for intranasal esketamine, highlighting its potential as treatment for patients with major depressive disorder who are at imminent risk for suicide and for those with treatment-resistant depression.
Janssen Research & Development announced today that the U.S. FDA has granted a breakthrough therapy designation for esketamine, an investigational antidepressant medication, for the indication of major depressive disorder with imminent risk for suicide. If approved by the FDA, esketamine would be one of the first new approaches to treat major depressive disorder available to patients in the last 50 years.
This also marks the second time esketamine has received a breakthrough therapy designation from the U.S. regulatory authority. Esketamine was first granted this designation for treatment-resistant depression in November 2013.
