J&J Antidepressant Gets FDA Breakthrough Therapy StatusBy
Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for esketamine, an investigational antidepressant medication for major depressive disorder with imminent risk for suicide.
This is the second breakthrough therapy designation that esketamine has received from the FDA. It was first granted this designation for treatment-resistant depression in November 2013. Esketamine is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist. The program in treatment-resistant depression is currently in Phase III, with six ongoing clinical trials.
Source: Johnson & Johnson