Finacea: US FDA Approved Topical Treatment for Rosacea

Rosacea is known to affect around 16 million Americans however, a survey by the National Rosacea Society found that 95 percent of rosacea patients had known little or nothing about its signs and symptoms prior to their diagnosis. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.

Recently, Bayer HealthCare Pharmaceuticals Inc. announced the US Food and Drug Administration approval of its product Finecea Foam (azelaic acid) 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

According to Bayer VP and General Manager, James Robins,

The FDA approval of Finacea® Foam is the result of several years of research and development. 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.

According to reports, 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. T

he severity of a subject's rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions. The clinical trials revealed that the use of Finacea resulted in a higher success rate in the reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period.

Finacea gel is usually applied twice daily, in the morning and at bedtime. This treatment will soon be available by prescription only beginning in September 2015.

For more info: