FDA, second Breakthrough Therapy Designation for intranasal Esketamine: major depressive disorder with imminent risk for suicide
The FDA ( Food and Drug Administration ) 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.
Breakthrough Therapy Designation is intended to expedite development and review timelines when preliminary clinical evidence indicates the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for serious or life-threatening conditions.
The Esketamine phase 2 clinical trial data provided preliminary clinical evidence to support the Breakthrough Therapy Designation for major depressive disorder with imminent risk for suicide.
In the U.S. alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly treated major depression.
Esketamine for intranasal administration is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate ( NMDA ) receptor antagonist. ( Xagena )
Source: Janssen, 2016