Allergan announced the U.S. Food and Drug Administration (FDA) 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.
"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," said David Nicholson, Chief Research and Development Officer, Allergan. "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."
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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.
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.
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. Additionally, the STAR*D trial reported that only 33% of patients reported remission of their MDD symptoms after monotherapy with an SSRI. In patients that do respond to an SSRI, numerous clinical trials have shown that it can take anywhere from 2 to 4 weeks for a patient to perceive and report that their depressive symptoms are improving. 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.