DUBLIN, Jan. 29, 2016 /PRNewswire/ -- Allergan plc.
(NYSE: AGN), a leading global pharmaceutical company today
announced that its Phase III ready investigational medication
rapastinel (GLYX-13) received Breakthrough Therapy designation from
the U.S. Food and Drug Administration (FDA) for adjunctive
treatment of Major Depressive Disorder (MDD). This follows the Fast
Track Designation for rapastinel granted by the FDA in 2014.
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"Rapastinel is the first Allergan medicine to be granted
Breakthrough Therapy designation by the FDA, underscoring our
commitment to innovative research and development that addresses
significant unmet medical needs. Breakthrough Therapy designation
will allow us to work more closely with the FDA to bring this
important therapy to patients as rapidly as possible," said
David Nicholson, Executive Vice
President and President of Global R&D brands at Allergan.
"There remains an unmet medical need for agents in depression that
demonstrate a rapid onset of action. We believe that rapastinel has
great potential to fulfill that unmet medical need in major
depressive disorder."
The Breakthrough Therapy designation was based on preclinical
and preliminary clinical evidence for rapastinel, which supports a
rapid (within 1 day) and sustained antidepressant effect over the
course of the Phase II studies. Rapastinel has been found to be
well tolerated in studies to date, with no psychotomimetic or
hallucinogenic side effects observed.
"Nonresponse to antidepressants is a key reason that major
depressive disorder is one of the United
States' leading public health problems and there is a great
need for new therapies that are truly different from those that are
currently used," said Dr. Michael E.
Thase, Professor of Psychiatry, Perelman School of Medicine
of the University of Pennsylvania and
the Corporal Michael J. Crescenz Veterans Affairs Medical Center in
Philadelphia, Pennsylvania.
"Rapastinel (GLYX-13) thus has great promise because it works
through a different pathway than conventional antidepressants and
may even work faster than standard therapies."
Enacted as part of the 2012 FDA Safety and Innovation Act
(FDASIA), Breakthrough Therapy designation is intended to expedite
the development and review of a potential new medicine if it is
intended to treat a serious or life-threatening disease and
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing
therapies. The Breakthrough Therapy designation is distinct
from FDA's other mechanisms to expedite drug development and
review.
Allergan plans to initiate phase 3 studies of rapastinel in
2016.
About rapastinel (GLYX-13)
Rapastinel (formerly known as GLYX-13) is an investigational
intravenous formulation of a novel NMDA receptor partial agonist,
which is being evaluated for adjunctive treatment of MDD, and has
shown a rapid onset of antidepressant efficacy 1 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. No
psychotomimetic or hallucinogenic side effects were observed with
rapastinel. A series of Phase 3 registration trials are planned to
begin in 2016. Rapastinel was granted Fast Track designation by the
FDA in 2014.
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 6
weeks for a patient perceive and report that their depressive
symptoms are improving. During these first 2 to 6 weeks of
traditional monoamine-based therapy, patients may continue to
experience significant depressive symptoms, which can include
suicidal ideation in patients with severe, recurrent, or chronic
depression.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing innovative branded pharmaceuticals, high-quality
generic and over-the-counter medicines and biologic products for
patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
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.
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 of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. 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; 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 Quarterly
Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings
having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc