FDA Approves New Topical Treatment for Rosacea
Finacea Foam is expected to be available by prescription only beginning in September
MONDAY, Aug. 3, 2015 (HealthDay News) -- A new prescription treatment for rosacea was approved on Monday by the U.S. Food and Drug Administration.
The FDA approved Bayer HealthCare's Finacea (azelaic acid) Foam, 15 percent, for topical treatment of mild to moderate rosacea, Bayer said in a news release. The approval is based on the results of two 12-week clinical trials that included 1,362 people, aged 19 to 92. The most common side effects of the foam were localized pain (6.2 percent of patients), pruritus (2.5 percent), dryness (0.7 percent), and erythema (0.7 percent).
There have been a few reports of hypopigmentation after the use of azelaic acid, and doctors should monitor patients with dark complexions for early signs of this problem, Bayer said. The company also cautioned that azelaic acid can irritate the eyes, and that Finacea Foam should not come into contact with the eyes, mouth, or other mucous membranes.
Finacea Foam will be available by prescription only beginning in September, according to Bayer.