Production & Manufacturing
Process & Production

Allergan’s AGN-241751 gets FDA fast track designation for MDD

Published 24 July 2018

The US Food and Drug Administration (FDA) has granted fast track designation for Allergan’s AGN-241751, an investigational drug for major depressive disorder (MDD).

AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development. 

Allergan chief research and development officer David Nicholson said: "The FDA's decision to grant Fast Track Designation for AGN-241751 corroborates our effort to develop new, highly innovative treatment options for patients with depression, an area of significant unmet need.

"We believe AGN-241751 will be an important oral complement to rapastinel, our fast-acting anti-depressant currently in Phase 3 development. The Fast Track designation will allow Allergan to work more closely with the FDA to bring AGN-241751 to patients as soon as possible."

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor (NMDAR) modulator. Allergan acquired AGN-241751 as part of its ongoing research effort with Aptinyx, Inc.

AGN-241751 development follows Rapastinel, which received FDA Fast Track Designation in 2014 and Breakthrough Designation from the FDA in 2016.

Rapastinel modulates the NMDA receptor through a unique and novel binding site to enhance glutamatergic activity, and is currently being studied in two Phase 3 clinical programs in patients with MDD, one as an adjunctive therapy and the other as a monotherapy treatment.

The adjunctive phase 3 clinical topline results are expected in 2019.

Additionally, Allergan is conducting a Phase 2 clinical trial of Rapastinel in MDD patients at imminent risk of suicide.

Rapastinel has shown a rapid onset of antidepressant efficacy one day after a single dose in a Phase 2 clinical trial of patients with MDD who had an inadequate response to one or more antidepressants.

Source: Company Press Release