A foam formulation of azelaic acid has been approved for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea, the manufacturer announced July 31.

Azelaic acid foam, 15%, was compared with a vehicle foam, applied twice a day for 12 weeks, in two studies with a total of 1,362 people with papulopustular rosacea (mean age 50.6 years) and a mean of about 21 inflammatory papules and pustules at baseline. The success rate was defined as a score of clear or minimal with at least a two-step reduction from baseline on the Investigator’s Global Assessment scale.

At 12 weeks, the success rate in the two studies, respectively, was 32% and 43% among those treated with azelaic foam vs. 23% and 32% among controls, according to the Bayer HealthCare press release announcing the approval.

The most common adverse events associated with treatment were pain at the application site in about 6%, pruritus (2.5%), dryness (0.7%), and erythema (0.7%). Warnings in the prescribing information note that treatment has been associated with “isolated” cases of hypopigmentation and can cause eye irritation, and that the contents are flammable. Patients are instructed to avoid “fire, flame, and smoking during and immediately following application.”

Azelaic acid foam is marketed as Finacea Foam by Bayer; it is the first foam formulation of azelaic acid to be approved, and it will be available in September, according to the company. A gel formulation of azelaic acid, 15%, was approved by the FDA in 2002 for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Serious adverse events associated with azelaic acid should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/default.htm .



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