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FDA Approves Azelaic Acid Foam (Finacea) for Topical Treatment of Rosacea

Product will be available in September

The FDA has given the green light to azelaic acid foam, 15% (Finacea, BayerHealthcare) for the topical treatment of the inflammatory papules and pustules of mild-to-moderate rosacea.

Rosacea is a chronic cutaneous disorder primarily affecting the convexities of the central face. There is no known cure. The disorder is most commonly 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 roles in its pathogenesis.

The FDA’s approval was based on results from two pivotal clinical trials that examined the efficacy and safety of azelaic acid compared with the foam vehicle (without azelaic acid) in the topical treatment of papulopustular rosacea, which causes inflammatory lesions (papules and pustules) on the nose, cheeks, chin, and forehead.

The two pivotal, randomized, double-blind, vehicle-controlled, 12-week studies involved a total of 1,362 subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range: 12 to 50) inflammatory papules and pustules. A total of 681 subjects received active treatment, and 681 received vehicle foam. The subjects were 19 to 92 years of age (mean age: 51 years); 96% were Caucasian; and 73% were female. The severity of a subject’s rosacea was based on scoring on the Investigator’s Global Assessment (IGA) scale as well as on a count of the inflammatory lesions.

In both trials, the subjects were randomly assigned to receive either azelaic acid foam, 15% or its foam vehicle twice-daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, whereas efficacy endpoints were assessed at the end of the 12-week treatment period. The co-primary efficacy endpoints were a nominal change in the inflammatory lesion count from baseline and treatment success, defined as a score of “clear” or “minimal” with at least a two-step reduction from baseline on the five-point IGA.

In both trials, treatment with azelaic acid foam resulted in a greater reduction in the mean nominal change in the inflammatory lesion count from baseline to the end of the 12-week treatment period compared with vehicle control (–13.2 vs. –10.3 in trial 1 and –13.3 vs. –9.5 in trial 2) as well as a higher IGA success rate (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2). The most common adverse events in the subjects treated with azelaic acid foam included local application-site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).

Finacea Foam will be available in the U.S. beginning in September 2015.

Source: BayerHealthcare; July 31, 2015.

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