FDA Okays Combination Gel for Mild-to-Moderate Acne
Posted on January 13, 2009
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FORT WORTH, Tex., Jan. 6 — For mild-to-moderate acne in patients 12 and older, the FDA has approved a once-a-day gel that combines adapalene and benzoyl peroxide gel (Epiduo Gel 0.1%, 2.5%), the drug maker announced.
According to Galderma, the combination gel “treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne.”
The approval followed a 517-patient phase II trial published last year in the Journal of the American Academy of Dermatology that found the gel reduced the median number of total acne lesions by more than 50% by the end of the 12-week study.
That was significantly better than monotherapy with either adapalene or benzoyl peroxide (median reduction in total lesion count 35.4% and 35.6%, respectively), said the company.
A long-term safety and efficacy study published last year in the Journal of Drugs in Dermatology found that discontinuation of the medication because of adverse events was low, occurring in 2% of all patients.
Common adverse effects included redness, scaling, dryness, stinging, and burning. Skin irritation and contact dermatitis may also occur.
Excessive exposure to sunlight and topical products containing resorcinol, salicyclic acid, and sulfur should be avoided while using the drug, said the company.
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Tags: Acne, Combination, Mild-to-Moderate, Okays
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