Allergan's anti-depressant candidate gets Breakthrough Therapy designation from US FDA

Ireland-headquartered Allergan (NYSE: AGN) said its anti-depression drug candidate has received Breakthrough Therapy status from the US Food and Drug Administration (FDA).

The investigational drug, rapastinel, also known as GLYX-13, is targeted to treat major depressive disorder (MDD). The drug has received a go-ahead from the regulators and the company plans to start Phase III trials in 2016. Rapastinel received fast track designation from the FDA in 2014.

Allergan’s president of Global R&D brands David Nicholson said: "Rapastinel is the first Allergan medicine 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.