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Title: FDA Approves Once-Daily Adapalene/Benzoyl Peroxide Gel for Acne Treatment

"FDA Approves Once-Daily Adapalene/Benzoyl Peroxide Gel for Acne Treatment"

NEW YORK -- January 6, 2009 -- The US Food and Drug Administration (FDA) has approved once-daily adapalene and benzoyl peroxide (Epiduo) gel 0.1%/2.5% for the treatment of mild to moderate acne. The gel treats both inflammatory and noninflammatory lesions with no evidence of promoting antibiotic resistance. The gel is more efficacious than either of its components used alone and significantly reduces total acne lesions by approximately 18% as early as the first week of treatment. It also helps to reduce the complexity of acne management by reducing the number of medications a patient has to remember to take on a daily basis, potentially increasing treatment adherence. "By targeting 3 out of the 4 causes of acne in a single medication, [adapalene/benzoyl peroxide] gel offers doctors and patients an efficacious, easy-to-use tool to tackle mild to moderate acne," said Linda Stein Gold, MD, Department of Dermatology at Henry Ford Hospital in Detroit. "Both adapalene and benzoyl peroxide have extensive histories of efficacy in treating acne, and the data demonstrates that [the] gel has an even more powerful treatment effect than either monotherapy without compromising tolerability." Results of a phase 2 trial involving 517 patients, published last year in the [Journal of the American Academy of Dermatology, demonstrated that adapalene/benzoyl peroxide gel reduced the median number of total acne lesions by more than 50% at the end of the 12-week study, which was significantly better than monotherapy with either adapalene (35.4% median reduction in total lesion count) or benzoyl peroxide (35.6% median reduction in total lesion count) alone. The gel combination therapy worked quickly, with some patients showing improvements after 1 week of therapy.

A long-term safety and efficacy assessment of the gel published last year in the Journal of Drugs in Dermatology showed that discontinuation of the medication due to adverse events was low, occurring in only 2% of all patients. Additionally, none of the 452 patients withdrew from the study as a result of a lack of efficacy.

These studies showed that the gel was well tolerated and rates of side effects were low with the majority of patients experiencing low levels of skin irritation associated with the drug.

SOURCE: Galderma

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