Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

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.

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"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.

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