The FDA approval is based on results from two pivotal clinical trials evaluating the efficacy and safety of Finacea Foam compared to the foam vehicle in the topical treatment of papulopustular rosacea, a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
In both the trials, treatment with Finacea Foam resulted in a higher Investigator’s Global Assessment (IGA) success rate compared to vehicle control, 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.
Bayer HealthCare Consumer Care division Innovation, Research & Development head Dr John O’Mullane said: "With the FDA’s approval of Finacea Foam we can now offer patients suffering from rosacea in the US a new treatment option.
"This demonstrates Bayer’s continued commitment to delivering innovation that meets the preferences and needs of patients with mild to moderate rosacea."
In these two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials, the most frequently observed adverse reactions in 0.5% of subjects treated with Finacea Foam included local application site pain, pruritus, dryness and erythema.
During the trials, subjects were randomized in a 1:1 ratio to receive either azelaic acid foam, 15% or its foam vehicle twice-daily for 12 weeks.
The company noted that Finacea Foam will be available in the US by prescription only beginning in September this year.
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.