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Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Finacea (azelaic acid) Foam 15% for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
The FDA approval was based on data from 2 multi-center, randomized, double-blind, vehicle-controlled 12-week clinical trials that studied the efficacy and safety of Finacea Foam vs. its foam vehicle (without azelaic acid) in the treatment of papulopustular rosacea (n=1,362). Treatment with Finacea Foam led to a higher Investigator’s Global Assessment (IGA) success rate vs. its vehicle control in Trial 1 (32.1% vs. 23.4%) and in Trial 2 (43.4% vs. 32.5%), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period in both Trial 1 (-13.2 vs. -10.3) and in Trial 2 (-13.3 vs. -9.5).
RELATED: Standard Tx for Rosacea May Not Be Superior
Finacea Foam 15% will be supplied as 50g cans starting in September 2015.
For more information call (866) 463-3634 or visit FinaceaFoam.com.
