Allergan plc. , a leading global pharmaceutical company announced that its Phase III ready investigational medication rapastinel (GLYX-13) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Major Depressive Disorder (MDD). This follows the Fast Track Designation for rapastinel granted by the FDA in 2014.
The Breakthrough Therapy designation was based on preclinical and preliminary clinical evidence for rapastinel, which supports a rapid (within 1 day) and sustained antidepressant effect over the course of the Phase II studies. Rapastinel has been found to be well tolerated in studies to date, with no psychotomimetic or hallucinogenic side effects observed.
Allergan plans to initiate phase 3 studies of rapastinel in 2016.
