FDA Approves New Rosacea Foam Treatment

The US Food and Drug Administration (FDA) today approved azelaic acid (Finacea Foam/Bayer) 15% for the treatment of inflammatory papules and pustules of mild-to-moderate rosacea.

Two pivotal clinical trials determined the efficacy and safety of Finacea Foam after comparing it to the alternative foam without the drug azelaic acid.

Results indicated that treatment with Financea Foam had a higher Investigator’s Global Assessment (IGA) success rate compared to placebo (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2).

Additionally, there was a large reduction in the inflammatory lesion count from baseline to the end of the 12-week period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2).

The most common reported adverse reactions to Financea Foam included local application site pain, pruritus, dryness, and erythema.

James Robins, VP & General Manager, Bayer HealthCare Pharmaceuticals Inc., said in a news release, “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.”

Finacea Foam is slated to be available by prescription in early September 2015.