WHIPPANY, N.J., July 31, 2015 /PRNewswire/ -- Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is 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.
In two pivotal clinical trials, treatment with Finacea® Foam resulted in a higher Investigator's Global Assessment (IGA) success rate compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2). The most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea® Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
"The FDA approval of Finacea® Foam is the result of several years of research and development," said James Robins, VP & General Manager, Bayer HealthCare Pharmaceuticals Inc. "Not only does it add to our current product line, it also demonstrates Bayer's continued commitment to addressing the needs of patients with mild to moderate rosacea."
Finacea® Foam will be available by prescription only beginning in September 2015.
About the Clinical Trials The efficacy and safety of Finacea® Foam was evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials (Trials 1 and 2) in subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules. A total of 1362 (active: 681; vehicle: 681) subjects aged 19 to 92 years (mean age = 50.6 years), 95.7% Caucasian, and 73.4% female participated in the trials. The severity of a subject's rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions.
In the clinical trials, subjects were randomized in a 1:1 ratio to receive either azelaic acid foam, 15% or the foam vehicle (without the drug azelaic acid) twice-daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period. The efficacy endpoints were 1.) nominal change in inflammatory lesion count from baseline and 2.) success defined as a score of "clear" or "minimal" with at least 2-step reduction from baseline on a 5-point IGA.
Finacea®(azelaic acid) Foam, 15%
INDICATION 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°F (49°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.
About Rosacea 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, agriculture and high-tech materials. 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.
Forward-Looking Statements 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.