New Rosacea Foam Treatment Approved by FDA

Finacea Foam showed a greater reduction in the average nominal change of inflammatory lesion count.

Finacea Foam showed a greater reduction in the average nominal change of inflammatory lesion count.

The FDA today approved azelaic acid foam 15% (Finacea) to treat inflammatory papules and pustules of mild to moderate rosacea.

Rosacea is a skin disease that often creates papules and pustules on the nose, cheeks, chin, and forehead. Clinical trials found Finacea Foam to be more effective than foam without acelaic acid to treat papulopustular rosacea.

The intervention treatment showed a greater reduction in the average nominal change of inflammatory lesion count from baseline after 12 weeks of twice-daily treatment. Finacea Foam also had a greater Investigator’s Global Assessment success rate compared with the control treatment.

The 2 clinical trials involved 1362 subjects, aged 19 to 92 years, with a mean lesion count of 21.3.

“With the FDA’s approval of Finacea Foam, we can now offer patients suffering from rosacea in the United States a new treatment option,” John O’Mullane, head of Innovation, Research, & Development at Bayer HealthCare’s Consumer Care division, said in a press release. “This demonstrates Bayer’s continued commitment to delivering innovation that meets the preferences and needs of patients with mild to moderate rosacea.”

Patients may experience adverse reactions such as local application site pain, pruritus, dryness, and erythema. Bayer HealthCare’s product is expected to become available in September 2015.