WHIPPANY, N.J., Oct. 26, 2015 /PRNewswire/ -- Bayer HealthCare announced today the availability of Finacea® (azelaic acid) Foam, 15%, at pharmacies nationwide. Finacea® Foam was approved in July 2015 by the U.S. Food and Drug Administration (FDA) for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
The approval was based on results from two pivotal clinical trials examining the efficacy and safety of Finacea® Foam compared to its foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
"The availability of Finacea® Foam offers physicians and rosacea patients an additional treatment option," said James Robins, VP & General Manager, Bayer HealthCare Pharmaceuticals Inc. "In conjunction with the ongoing Rosacea Concierge program, we continue in our efforts to support those impacted by mild to moderate rosacea."
Bayer is offering a prescription payment assistance program for patients who are prescribed Finacea® Foam. The program includes a $0 initial co-pay for the first prescription (with a maximum benefit of $175) and significant savings on subsequent refills. For more information, log on to www.FinaceaFoam.com.
Finacea® (azelaic acid) Foam, 15%
Finacea® (azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.
Eye and Mucous Membranes Irritation: Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a healthcare professional if eye irritation persists.
Flammability: The propellant in Finacea® Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120 degrees F (49 degrees C).
Most Common Adverse Reactions
In clinical studies, the most frequently observed adverse reactions in > 0.5% of subjects treated with Finacea® Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
For Topical Use Only
Finacea® Foam is not for oral, ophthalmic or intravaginal use.
Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, see the full Prescribing Information at www.finaceafoam.com or http://labeling.bayerhealthcare.com/html/products/pi/Finacea_Foam_PI.pdf.
Rosacea is a chronic cutaneous disorder primarily affecting the convexities of the central face. There is no known cure. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact etiology of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on the pathogenesis of this disease. To learn more about rosacea, please visit www.rosacea.org.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no obligation whatsoever to update these forward-looking statements or to adjust them to include future events or developments.
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Bayer Healthcare LLC
SOURCE Bayer HealthCare LLC