FDA approves Bayer HealthCare topical rosacea treatment

WHIPPANY, N.J. — Bayer HealthCare Pharmaceuticals on Friday announced that the Food and Drug Administration approved the company’s Finacea (azelaic acid) Foam, 15% for the topical treatment rosacea.

The foam specifically treats the inflammatory papules and pustules that result from a mild to moderate form of the condition, and will be available by prescription only in September.

"The FDA approval of Finacea Foam is the result of several years of research and development," James Robins, Bayer HealthCare VP and general manager, said. "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."

The FDA approval is based on results from two clinical trials that examined Finacea Form’s efficacy and safety, compared to its foam vehicle without the drug azelaic acid in the the topical treatment of papulopustular rosacea, the company said.

Treatment with Finacea Foam resulted in a higher Investigator's Global Assessment success rate, compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), in addition to a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2), according to the company.

Adverse reactions, which included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%) and erythema (0.7%), were observed in more than 0.5% of subjects treated with Finacea Foam.