Allergan plc, a global pharmaceutical company, has announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development.
Approximately 16 million Americans are living with Major Depressive Disorder (MDD). There remains a significant unmet need in treating MDD. Upwards of 70% of patients with MDD are partial or non-responders to first-line therapies which include SSRIs and SNRIs. Patients with an incomplete response to traditional, monoamine-targeted therapies may continue to experience significant depressive symptoms, which can include suicidal ideation in patients with severe, recurrent, or chronic depression
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.
David Nicholson, Chief Research and Development Officer, Allergan 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.”