Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea® Foam compared to its foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
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%).
‘The FDA approval of Finacea® Foam is the result of several years of research and development,’ said James Robins, VP & General Manager, Bayer HealthCare Pharmaceuticals Inc. ‘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 will be available by prescription only beginning in September 2015.
About the Clinical Trials
The efficacy and safety of Finacea® Foam was evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials (Trials 1 and 2) in subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules. A total of 1362 (active: 681; vehicle: 681) subjects aged 19 to 92 years (mean age = 50.6 years), 95.7% Caucasian, and 73.4% female participated in the trials. The severity of a subject’s rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions.
In the clinical trials, subjects were randomized in a 1:1 ratio to receive either azelaic acid foam, 15% or the foam vehicle (without the drug azelaic acid) twice-daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period. The efficacy endpoints were 1.) nominal change in inflammatory lesion count from baseline and 2.) success defined as a score of ‘clear’ or ‘minimal’ with at least 2-step reduction from baseline on a 5-point IGA.