DUBLIN, July 23, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today 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.
"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."
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.
About Major Depressive Disorder (MDD)
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.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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