The U.S. Food and Drug Administration (FDA) gave its nod to Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild-to-moderate rosacea.
Finacea® Foam will be available by prescription only beginning in September 2015.
In two pivotal clinical trials, treatment with Finacea® Foam resulted in a higher Investigator’s Global Assessment (IGA) success rate compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), 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 (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2).
The most frequently observed adverse reactions in ? 0.5% of subjects treated with Finacea® Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
