Allergan’s repastinel gets Breakthrough Therapy designation for MDD

DUBLIN — Allergan announced Friday that the Food and Drug Administration had given its Breakthrough Therapy designation to the company’s rapastinel as an adjunctive treatment for major depressive disorder. 

 

“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,” Allergan EVP and president of global research and development brands David Nicholson said. “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.”

 

This designation follows the FDA granting it Fast Track status in 2014. The drug showed in clinical trials that it had a sustained antidepressant effect following a one-day rapid effect.