REDUCING REDNESS FOR ROSACEA PATIENTS
~ New FINACEA® offers patients a fast acting treatment option and new online resource ~
June 22, 2010 @ 08:00AM
Toronto, ON – Canadians struggling to treat their rosacea now have a new treatment option with FINACEA® (azelaic acid gel). Now available in Canada as an effective and safe anti-rosacea agent, FINACEA® is a topical treatment for inflammatory papules, pustules and flushing or redness caused by mild to moderate rosacea – symptoms many people with rosacea often struggle to treat or conceal.
“Rosacea can be a frustrating condition for patients as it is visible for all to see – facial flushing, redness and pimples,” said Dr. Jerry Tan, Canadian dermatologist, member of the Canadian Dermatology Association and adjunct professor at the University of Western Ontario. “Rosacea patients are taught to avoid triggering factors such as excessive sun exposure, alcohol, spicy foods, and to use make-up and sun blocks. Current treatments range from topical antibiotics applied to the skin, antibiotic pills, and laser/pulse light therapy. FINACEA is a topical treatment that will provide a welcome new option for patients.”
The availability of FINACEA® in Canada offers Canadian patients who are unsatisfied with existing therapies a new treatment option to manage mild to moderate rosacea symptoms. FINACEA® has been available in other countries for a number of years and is the most prescribed topical treatment for rosacea in the United States by dermatologists.1 Now Canadians have access to this effective product through their dermatologist.
Rosacea – The Facts
There are approximately two million Canadians living with rosacea.2 While rosacea can affect anyone, the skin disorder is more prevalent among Caucasians, mostly women, between the ages of 30 and 50 years old.2,3
Rosacea is commonly identified by noticeable redness and dryness on a person’s cheeks, chin, nose and central forehead.4 The facial lesions that accompany rosacea can cause a patient to experience low self-esteem and frustration5, particularly with finding a treatment that helps to reduce the symptoms of this visual and hard to cover skin disorder.
FINACEA® – What the Data Shows
Bayer’s application to Health Canada for the approval of FINACEA® was based on data from quality control studies, as well as data from pre-clinical and clinical studies.6 Several studies show that FINACEA® reduces the redness and swelling of rosacea.3 Results from two identical phase III multi-centre, double-blind, randomized studies involving 664 patients, showed that almost all (90 per cent) considered the tolerability of FINACEA® to be good or acceptable.3 Some patients who used FINACEA® saw their symptoms improve in as few as four weeks.7 In one clinical trial, FINACEA® patients experienced continued improvement through the entire 15 weeks of the study, compared to the other patient group using another topical treatment who stopped showing continued improvement after eight weeks.8
FINACEA® is intended for topical use only. A thin layer of FINACEA® (0.5 g or approximately 2.5 cm of gel) should be applied twice daily to the affected areas continuously over the entire period of treatment.9
The duration of use of FINACEA® can vary from person to person and also depends on the severity of the rosacea. Significant initial therapeutic effects have been observed after four to eight weeks of treatment.9,3
In clinical trials, FINACEA® was generally well tolerated. Common side effects included burning, itching, stinging and dry skin. Less common side effects included rash.9
FINACEA® – Online for Patients
FINACEA® is marketed in Canada by Bayer HealthCare Pharmaceuticals. Bayer recognizes that many Canadians with rosacea, particularly women, are seeking health information online. In response to the demand for online resources, rosacea patients who are prescribed the new FINACEA® gel will have exclusive access to www.finacea.ca. In addition to providing patients with Canadian content about the skin disorder and the treatment they have been prescribed, this website also offers information about new ways of filling their prescription. And for physicians, FINACEA® samples can be ordered online by simply visiting www.finacea.ca and logging on to the healthcare provider section.
Rosacea patients who are interested in trying FINACEA® should talk to their dermatologist. Once prescribed FINACEA®, patients can use the DIN* to access www.finacea.ca.
* A Drug Identification Number (DIN) is an eight digit number located on the label of prescription and over-the-counter drug products authorized for sale in Canada.
REFERENCES
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Wolters Kluwer PHAST, April 2010.
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Canadian Skin Patient Alliance website. Rosacea. Incidence. Available at: http://www.skinpatientalliance.ca/en/skin-conditions-diseases/rosacea/incidence
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Thiboutot D, Thieroff-Ekerdt R, Graupe K. Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies. J Am Acad Dermatol. 2003;48(6):836-845.
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Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46:584-587.
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Canadian Skin Patient Alliance website. Rosacea. Impacts to Quality of Life. Available at:
http://www.skinpatientalliance.ca/en/skin-conditions-diseases/rosacea/impacts-quality-life -
Health Canada Website. Notice of Decision for Finacea. Available at http://www.hc-sg.gc.ca/dhp/mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2006_finacea_092975-eng.php
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myFINACEA.com website. Works Quickly. Available at: http://www.finacea-us.com/
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Elewski BE, Fleischer AB Jr, Pariser DM. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. Arch Dermatol. 2003;139(11):1444-1450.
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Bayer Inc. Finacea (Azelaic Acid Gel) 15% gel product monograph. Part III: Consumer Information. Toronto, ON. February 22, 2010.
Boilerplate
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians – producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.
Bayer Inc. has approximately 800 employees across Canada and had sales of $853 million CDN in 2009. Globally, the Bayer Group had sales of over 31 billion Euro in 2009. Bayer Inc. invested approximately $50 million CDN in research and development in 2009. Worldwide, the Bayer Group spent the equivalent of over 2.7 billion Euro in 2009 in R&D. For more information, go to www.bayer.ca.


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