Allergan's investigational medication rapastinel granted FDA Breakthrough Therapy designation

Allergan plcJan 29 2016

Allergan plc. (NYSE: AGN), a leading global pharmaceutical company today 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.

"Rapastinel is the first Allergan medicine to be granted Breakthrough Therapy designation by the FDA, underscoring our commitment to innovative research and development that addresses significant unmet medical needs. Breakthrough Therapy designation will allow us to work more closely with the FDA to bring this important therapy to patients as rapidly as possible," said David Nicholson, Executive Vice President and President of Global R&D brands at Allergan. "There remains an unmet medical need for agents in depression that demonstrate a rapid onset of action. We believe that rapastinel has great potential to fulfill that unmet medical need in major depressive disorder."

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.

"Nonresponse to antidepressants is a key reason that major depressive disorder is one of the United States' leading public health problems and there is a great need for new therapies that are truly different from those that are currently used," said Dr. Michael E. Thase, Professor of Psychiatry, Perelman School of Medicine of the University of Pennsylvania and the Corporal Michael J. Crescenz Veterans Affairs Medical Center in Philadelphia, Pennsylvania. "Rapastinel (GLYX-13) thus has great promise because it works through a different pathway than conventional antidepressants and may even work faster than standard therapies."

Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), 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 FDA's other mechanisms to expedite drug development and review.

Allergan plans to initiate phase 3 studies of rapastinel in 2016.