FDA approves new topical rosacea treatment

FDA has approved azelaic acid (Finacea, Bayer HealthCare) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

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According to the National Rosacea Society, an estimated 16 million Americans have rosacea, although only a small percentage of those affected by the condition are aware of it. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.

This marks the first and only foam formulation of Finacea on the market. Finacea Gel 15% was FDA approved in December 2002, and released in March 2003.

The approval is based on results from 2 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.

Finacea Foam, 15% was shown to be superior to its vehicle in the treatment of rosacea in reducing the number of inflammatory papules and pustules and demonstrating success according to Investigators Global Assessment (IGA) at the end of treatment.

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The efficacy and safety of Finacea Foam was evaluated in 2 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 1,362 (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.

The price of Finacea Foam, 15% varies, according to Tiffany Smith, communications, Bayer. “Patients should speak to their healthcare provider if they have questions."

A patient support program is offered, according to Smith. “Patients may pay as little as $30 with a cap of $100 for Finacea Foam, 15%.”

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