DUBLIN, Jan. 19, 2017 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company, announced
today the approval of RHOFADE™ cream by the U.S. Food and Drug
Administration (FDA) for the topical treatment of persistent facial
erythema (redness) associated with rosacea in adults. Approval was
based on two clinical studies that evaluated the primary efficacy
endpoint on day 29.1
"The FDA approval of RHOFADE™ exemplifies Allergan's commitment
to continuing to address unmet patient needs through innovation in
medical dermatology," said David
Nicholson, Chief R&D Officer of Allergan plc. "We know
persistent facial erythema associated with rosacea is a challenge
for patients and physicians and having options can help in treating
the disease. RHOFADE™ is the first and only alpha1A
adrenoceptor agonist approved for persistent facial erythema
associated with rosacea in adults. The FDA approval of RHOFADE™
represents a new prescription treatment that can effectively help
physicians and their patients manage this
condition."
The National Rosacea Society (NRS) estimates that approximately
16 million Americans are affected by rosacea.2
Persistent facial redness is cited as the most common sign of
rosacea, and may resemble a flushing or sunburn that does not go
away.3 Typical triggers include sun exposure, stress,
weather, food, exercise and/or products.4 In an NRS
survey, 65% of rosacea patients surveyed said their symptoms first
appeared between 30-60 years of age.5
"Historically, there haven't been many options available to help
physicians address persistent facial erythema and often we ended up
just helping our patients identify and manage triggers, which can
lead to frustration for both the doctor and patient," said Dr.
Robert Weiss, Clinical Trial
Investigator and Director of Maryland
Laser, Skin & Vein Institute. "With the approval of
RHOFADE™, doctors will now be able to provide their patients with
an effective once-daily treatment option to help manage this
condition."
In two clinical trials, a once-daily application of RHOFADE™ was
proven to reduce persistent facial erythema associated with rosacea
through 12 hours. The primary efficacy endpoint was at day 29 and
defined as the proportion of patients with at least a 2-grade
reduction in erythema (improvement) from baseline (pre-dose on day
1) on both the clinician erythema assessment (CEA) and subject
self-assessment (SSA) (composite success) measured at hours 3, 6, 9
and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15
at hours 3, 6, 9, and 12.1
The clinical trials were identical, multicentered, randomized,
double-blind, parallel-group, and vehicle-controlled in moderate or
severe patients, N=885, 18 years or older.1
In both pivotal trials, the primary efficacy endpoint was met.
The proportion of patients achieving composite success were as
follows: at hours 3, 6, 9 and 12 results in study 1 were RHOFADE™
(N=222) 12%, 16%, 18%, 15% versus Vehicle (N=218) 6%, 8%, 6%, 6%
and in study 2 were RHOFADE™ (N=224) 14%, 13%, 16% and 12% versus
Vehicle (N=221) 7%, 5%, 9% and 6%. RHOFADE™ was proven more
effective than vehicle in reducing persistent facial erythema
associated with rosacea in adults.1
RHOFADE™ will be available for commercial supply starting
May 2017 in the United States. For more information, visit
www.Rhofade.com.
RHOFADETM (oxymetazoline hydrochloride)
cream, 1% Indication and ISI
Indication
RHOFADETM (oxymetazoline hydrochloride) cream,
1% is indicated for the topical treatment of persistent facial
erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS"
Potential Impacts on
Cardiovascular Disease
Alpha-adrenergic agonists may impact
blood pressure. RHOFADETM should be used with
caution in patients with severe or unstable or uncontrolled
cardiovascular disease, orthostatic hypotension, and/or
uncontrolled hypertension/hypotension. Advise patients with
cardiovascular disease, orthostatic hypotension, and/or
uncontrolled hypertension/hypotension to seek immediate medical
care if their condition worsens.
Potentiation of Vascular
Insufficiency
RHOFADETM should be used with
caution in patients with cerebral or coronary insufficiency,
Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or
Sjögren's syndrome. Advise patients to seek immediate medical
care if signs and symptoms of potentiation of vascular
insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADETM
may increase the risk of angle closure glaucoma in patients with
narrow-angle glaucoma. Advise patients to seek immediate medical
care if signs and symptoms of acute angle closure glaucoma
develop.
ADVERSE REACTIONS
The most common adverse reactions for RHOFADETM were:
application site dermatitis 2 %, worsening inflammatory lesions of
rosacea 1%, application site pruritus 1%, application site erythema
1%, and application site pain 1%.
Please see accompanying RHOFADETM full Prescribing
Information.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing branded pharmaceuticals, devices and biologic
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, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 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 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 Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016 (certain of 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.
References:
1 RHOFADE™ Prescribing Information,
2017
2 National Rosacea Society,
https://www.rosacea.org/rr/2010/winter/article_1.php, Last accessed
on January 18, 2017
3 National Rosacea Society,
https://www.rosacea.org/patients/allaboutrosacea.php, Last accessed
on January 18, 2017
4 National Rosacea Society,
https://www.rosacea.org/rr/2002/summer/article_3.php, Last accessed
on January 18, 2017
5 National Rosacea Society,
https://www.rosacea.org/weblog/risks_answer_why_me, Last accessed
on January 18, 2017
© 2017 Allergan. All rights reserved. All trademarks are the
property of their respective owners.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-announces-fda-approval-of-rhofade-oxymetazoline-hydrochloride-cream-1-for-the-topical-treatment-of-persistent-facial-erythema-associated-with-rosacea-in-adults-300393385.html
SOURCE Allergan plc