Galderma Laboratories, L.P. today announced the availability of Epiduo (adapalene and benzoyl peroxide) Gel 0.1% / 2.5%, the first and only, once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene, and benzoyl peroxide, a well-known antimicrobial with no evidence of promoting bacterial resistance. The new prescription acne treatment received approval from the U.S. Food and Drug Administration in December, and will be on pharmacy shelves nationwide in the first quarter of 2009.
Because acne is caused by a multitude of factors, management of the condition has traditionally relied on combination therapy. Established consensus guidelines recommend the use of a topical retinoid and an antimicrobial as first-line therapy for the majority of acne patients. By combining the two effective medications into one product, Epiduo Gel treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne. Additionally, studies indicate that Epiduo Gel is more efficacious than either of its components used alone and significantly reduces total acne lesions by approximately 18 percent as early as the first week of treatment.
Epiduo Gel also helps 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. The easy-to-apply Gel requires use only once a day.
"By targeting three out of the four causes of acne in a single medication, Epiduo Gel offers doctors and patients an efficacious, easy-to-use tool to tackle mild-to-moderate acne," said Dr. Linda Stein Gold, director of clinical research and division head 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 Epiduo Gel has an even more powerful treatment effect than either monotherapy without compromising tolerability."
A 517-patient Phase 2 trial of Epiduo Gel published last year in the Journal of the American Academy of Dermatology demonstrates that Epiduo Gel reduced the median number of total acne lesions by more than 50 percent at the end of the 12-week study, which was significantly better than monotherapy with either adapalene (35.4 percent median reduction in total lesion count) or benzoyl peroxide (35.6 percent median reduction in total lesion count) alone. In addition, the Epiduo Gel combination therapy worked quickly, with some patients showing improvements after one week of therapy.
A long-term safety and efficacy assessment of Epiduo 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 percent of all patients. Additionally, none of the 452 patients withdrew from the study as a result of a lack of efficacy.
These studies also showed that Epiduo Gel is well-tolerated, and rates of side effects were low in all Epiduo Gel groups. Clinical trials have demonstrated that Epiduo Gel is well-tolerated from week 1 to week 52, with the majority of patients experiencing low levels of skin irritation associated with the drug.
"The recent FDA approval and upcoming availability of Epiduo Gel are examples of Galderma's strong research and development capabilities and our ongoing commitment to providing innovative treatment options to patients," said Albert Draaijer, President, Americas, Galderma Laboratories, L.P. "As an industry leader in the dermatology space, our goal is to help improve physicians' abilities to offer individualized treatment approaches to the management of acne and other emotionally burdensome skin conditions."