DUBLIN, May 24, 2016 /PRNewswire/ -- Allergan plc (NYSE:
AGN) today announced that the New Drug Application (NDA) filing for
oxymetazoline HCl cream 1.0%, an investigational topical
prescription product for the treatment of persistent facial
erythema (redness) associated with rosacea in adults, has been
accepted by the U.S. Food and Drug Administration (FDA)
for standard review. Allergan expects the Prescription Drug User
Fee Act (PDUFA) date to be in the first half of 2017.
Logo -
http://photos.prnewswire.com/prnh/20150612/222796LOGO
"While rosacea is a common chronic skin condition that affects
more than 16 million people in the U.S. alone1, there is
a significant unmet need in effective, FDA-approved treatments for
the condition," said David Nicholson, Chief R&D Officer,
Allergan. "The NDA filing of oxymetazoline speaks to our strong
commitment to ongoing innovation of our medical dermatology
portfolio, and we look forward to bringing a new treatment option
to patients with rosacea."
About Oxymetazoline
Oxymetazoline is a sympathomimetic agonist that is selective for
the α1A-adrenoceptor over other α1-adrenoceptors and non-selective
for the α2-adrenoceptors. As such, oxymetazoline is a potent
vasoconstrictor of the cutaneous microvasculature. The NDA
submission for oxymetazoline HCL cream 1.0% was based on data
collected from two phase 3 pivotal clinical trials of a 29-day
treatment duration and a 1-year open label clinical trial. These
studies enrolled male and female patients ≥ 18 years of age with
moderate to severe persistent facial erythema associated with
rosacea.
About Rosacea
Rosacea is primarily an adult condition, with onset of symptoms
generally occurring between the ages of 30-60 years of
age.2
The diagnosis of rosacea is made based on the presence of one or
more primary features centrally distributed on the face, including
flushing, persistent redness, bumps and blemishes, and/or visible
blood vessels.3 While the pathophysiology of rosacea
remains largely unknown, it is thought to be a chronic,
inflammatory and vascular disorder. Rosacea is not curable, and it
generally requires long-term treatment to alleviate symptoms and
delay or prevent disease progression. There are limited topical
treatment options for persistent facial redness associated with
rosacea available on the market today.
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 December 31,
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.
1 National Rosacea Society. "Rosacea Now Estimated to
Affect At Least 16 Million Americans." Available online at:
http://www.rosacea.org/rr/2010/winter/article_1.php Last
accessed on May 18, 2016
2 Moustafa F, Lewallen RS, Feldman SR. The
psychological impact of rosacea and the influence of current
management options. J Am Acad Dermatol. 2014;71:
973-980.
3 National Rosacea Society. "Classification of Rosacea."
Available online at
http://www.rosacea.org/class/classysystem.php Last accessed
on May 18, 2016
4 Del Rosso, J. Advances
in Understanding and Managing Rosacea Part 1. The Journal of
Clinical and Aesthetic Dermatology, 2012; 5 (3): 21-22.
CONTACTS:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(973) 906-1526
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-announces-fda-acceptance-of-nda-filing-for-oxymetazoline-hci-cream-10-300273670.html
SOURCE Allergan plc