FDA Fast-Tracks Novel Treatment for Major Depressive Disorder
An investigational treatment for major depressive disorder (MDD), AGN-241751 (Allergan), has been granted Fast Track designation by the Food and Drug Administration (FDA).
AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor (NMDAR) modulator currently being evaluated in a Phase 2 double-blind, placebo-controlled, fixed-dose study involving 250 participants with MDD. The primary outcome measure of the study is change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score.
AGN-241751 is being developed in tandem with rapastinel, an investigational intravenous formulation of a novel NMDA receptor partial agonist, currently in Phase 3 development for MDD, as both a monotherapy and an adjunctive treatment. Results from the Phase 3 adjunctive treatment trial are expected in 2019.
"We believe AGN-241751 will be an important oral complement to rapastinel," said David Nicholson, Chief Researcher and Development Officer, Allergan. "The Fast Track designation will allow Allergan to work more closely with the FDA to bring AGN-241751 to patients as soon as possible."
Rapastinel is also being investigated in a Phase 2 trial in MDD patients at immediate risk of suicide.
For more information visit Allergan.com.