FDA Grants Breakthrough Therapy Status for Allergan’s AntidepressantBy
The US Food and Drug Administration (FDA) has granted Allergan's investigational medication, rapastinel, breakthrough therapy designation for adjunctive treatment of major depressive disorder (MDD). This follows the fast track designation for rapastinel granted by the FDA in 2014.
Breakthrough therapy designation is intended to expedite the development and review of a potential new medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The breakthrough therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.
Allergan plans to initiate Phase III studies of rapastinel in 2016. Rapastinelis an investigational intravenous formulation of a N-methyl-D-aspartate receptor partial agonist.