FDA approves Finacea Foam, 15% for treating papulopustular rosacea

Bayer HealthCare announced today in a press release that the FDA has approved Finacea Foam, 15% as topical treatment of mild to moderate papulopustular rosacea.

The FDA based the approval on results of two clinical trials that examined the efficacy and safety of Finacea (azelaic acid) Foam, 15% compared with the foam vehicle without azelaic acid as topical treatment of papulopustular rosacea, according to the press release. Papulopustular rosacea causes inflammatory lesions on the nose, cheeks, chin and forehead, the release stated.

In the trials, patients treated with Financea Foam had a greater Investigator’s Global Assessment success rate compared with the control cohort treated with vehicle foam (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2, respectively). Greater reduction in mean nominal change of inflammatory lesion count from baseline to 12 weeks of the treatment also was observed in the Finacea-treated cohort, according to the release

Adverse reactions reported included local application site pain, pruritus, dryness and erythema, according to the release.

The product will be available in the United States by prescription beginning in September, the release stated.

Reference: www.healthcare.bayer.com