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.
Forward-Looking Statement
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.
CONTACTS:
Allergan:
Investors:
Daphne
Karydas
(862) 261-8006
Karina Calzadilla
(862) 261-7328
Media:
Amy Rose
(862) 289-3072
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SOURCE Allergan plc